FlexNExT owners; what color do you have?

yeh

Did you mean this

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or his body squishpack

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yep that’s it.

ok… so… I’ve been thinking about this rash problem because in all my years of selling things have I never seen rashes like this (and @Az_F)… I mean it just kept gnawing at me … why would there be this kind of reaction in such a high percentage of people getting these large flex when it’s the same materials used for other flex… and I think I figured it out… and it sucks and I’m pissed at myself.

The small flex used to ship in tubes. The tubes were ok, but the o-ring was not perfect and would not contain the chlorhex and alcohol long term… eventually it would all sneak out… but when it came time to start shipping much bigger flex devices, it would no longer do anyway… so I came up with the “squishpack” concept… a traditional sterilization pouch heat sealed inside a thick poly bag with chlorhex. The pouches have this little adhesive flap that let you slide the device in, then close it up. Normally these go in an autoclave, but since we can’t autoclave I just use it to ensure the device is still able to be minimally handled once removed from the poly bag without contamination. It worked well and let the installer drop the pouch out and let everything “dry” and then still be able to handle the pouch on the field until they open it and drop the device to the field itself.

Well, the first squishpacks I made also had a leakage problem… turns out the heat sealing I was doing on the poly was being rushed and vapor was trapping itself in the plastic bead and allowing a kind of osmosis bridge for alcohol to slowly leech out. I ended up revising my heat seal approach, and in the process, decided to also stop using the adhesive flap and just cut it off and heat seal the pouch itself too.

After thinking hard about this rash issue, I realized that the only actual difference here is the sterilization pouch… and the fact that it has this adhesive flap.

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A while back I put some pouches into bags with nothing inside and put different types of antiseptics inside including chlorhex, isopropyl, and ethenol (with denaturing agent). After the discussion about how strange bodies are acting I pulled these out and started looking at the adhesive flap. It turns out that the mixture of chlorhex and denatured ethanol, which I was using in these packs, basically breaks the adhesive down (which is mostly galactomannan polysaccharide and soy based) and puts a tiny film of it all over the inside of the poly bag… and presumably the implant as well. The chlorhex with isopropyl did not do this, but it made the adhesive basically puff up like a sponge, which is really odd.

So basically @anon3825968 when you asked if I rubbed the implants on a cat before shipping, in a way they actually were tainted. The adhesive itself is supposed to be “medical grade” and non-toxic, but that doesn’t mean you can’t have an allergic reaction to it… and I think that’s what was happening here… so while your body was basically fighting to absorb and remove it, you were both getting rashes and odd reactions.

This really is a horrible oversight by me and I sincerely apologize to you and everyone who may have implanted devices with this problem. I estimate I shipped about 25 or so such devices, and so far the only rashes or difficulties I’ve heard of are @anon3825968 and @Az_F, but that doesn’t mean there aren’t any other cases.

If anyone has had an adverse reaction to a flex device sold in the last 6 months, including flexM1, flexMT, flexDF2, and flexNExT… please contact me. I want to hear about your case.

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Okay. Thanks a lot for your candor. Like I said before, that’s why I keep coming back here: I value honesty and I sure get plenty of it here.

That said, don’t beat yourself up in my case, because that rash lasted 12 hours, happened over 3 weeks after the implantation, was barely visible, and went away almost as fast as it came in. Whatever it was, it was probably not a film of allergen on the implant - not that long after the install. Azflyer’s case might be different though.

Now that you explained this though, I’m beginning to wonder if the collagen flareups, tendon adherence, skin stickiness and various other general weirdness might have been caused by this. Unlikely, as it all started exactly two weeks after the install, and half an hour after getting the stitches out. If all this was caused by something external, it must have been a bug on the stitches that got in and instantly got to work on my case. But who knows…

Thanks for the detailed explanation in any case. I really do appreciate.

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Incidentally, is it just me of that thread has been comprehensively derailed at this point? :slight_smile:

Sorry Cobble :slight_smile:

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you’re good lol, I think I might’ve settled on deep blue already anyways

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derail

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Sure you don’t want yellow? I recommend yellow: it’s the best deep orange you never saw! :slight_smile:

By the way Amal, the flexM1 I had installed the same day as the doNExT came in a baggie also, not in a tube, and I seem to remember it had that sticker inside too. I’m almost certain because I remember thinking I’d better not mix up the baggies. Unfortunately I ain’t got no photo of that one.

I got zero reaction from the flexM1.

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good to know! still worth putting out an advisory for… I’ve already got one coming back that was purchased but no chance to install yet… potentially two… so it’s better to be safe than sorry.

Nah, orange ain’t really my color

Well, even if your “oversight” was the cause, I’m unlikely to return the product I am? :slight_smile:

I put oversight in quotes because that seems really minor to me. The cretin surgeon who messed up my knee with a simple meniscectomy last year created one really annoying problem for me, he was a fully qualified surgeon, and he didn’t give half the fuck you seem to give. And I’ve been reliably informed by my lawyer that I’d never win against him if I sued, because it would fall in the “oops, that happens” category.

So I’d say keep on doing what you’re doing, but really don’t beat yourself up. It is my impression that you go beyond the call of duty anyway - especially considering what “others” are doing.

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Orange wins elections my friend. You could be the next prez. Think about it :slight_smile:

You are leading the way with this tech, and using safe practices, your logic was sound, you have identified, notified and rectified the “problem.”
I still haven’t installed my FlexMT, and it came in that original flap squishie… If I had installed it and I had issues, trust me, I would not be cursing you.
Your intent is clear, and you’re smart enough to not intentionally harm your customer base

The fact you feel bad speaks volumes about you and your company

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Thanks man… I’m annoyed I didn’t think of it… glad it’s not proven to be much more than a couple rash cases… basically.

Have you sent a help message to get it sorted?

Amal, that there is my yet unimplanted FlexEM: Is that the same packaging? Should I hit the help button also or is it cool?

Same issue… the flap is there. Hit the help button and we’ll get it sorted. Include your flexEM order number I’m the request and if you have moved since the order include your new address.

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Okay very groovy. I’ll get right on that.
Thanks!

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At least one of them ended up inside my hand, and I had (until now) no big issues. So, whatever it is, it seems like I’m not allergic to it - quite a surprise, because my skin likes to react to a lot of things.
But I really like the way you found the problem and adressed it here - so it’s no longer a mysterious reaction of the skin, but rather a little fault that led to unexpected problems. Things like this happen, you already solved the problem and everyone’s informed - that’s the best way you could deal with it, it’s professional and it shows that you deserve the trust we all put in you :wink:

Oh, and to de-derail this post - I’ve got the bright blue blinkies, they were red for quite a long time, then they turned into a really bright blue, and now (since it’s swollen again), they are mostly a mixture of white, green and blue. Ah, one of them is more reddish, again. For some time, one LED was even two-toned - half of it was blue, half of it was red. So, expect everything :smiley:

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