For a short time, we sold flex products in a standard sterilization pouch with this flap;
We have discovered that the liquid antiseptic solution used in the sealed polymer bag had in many cases dissolved some of the adhesive (which is mostly galactomannan polysaccharide and soy based) which could come to rest on the implant device itself. 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.
New packaging does not include this flap as the sterilization pouch has been heat sealed instead, like this;
If you have installed such a device and noticed a rash that lasted for any amount of time, please contact us to tell us about it.
If you have a product that is not yet installed that has this flap, please contact us right away for a free replacement.
If you have implanted a device from a sterilization pouch that had this adhesive flap and have experienced no rash or itching, or you have had a rash but it has subsided, there is no need to remove your implant. Your body has removed and broken down any potential adhesive that made its way to the surface of your flex device. Of course, you should consult your doctor if you have any concerns.
I’ll be Blinky, the yellow dotted line will be my arm pointing somewhere with the Sentero and the yellow circle is the same what you marked with yellow circle as well.
Most companies these days get scared and don’t admit if something isn’t / wasn’t right
In the firearms industry both where I work, and what I have done in the past gunsmithing and such I have always held and preached
It’s not how long you go without fucking up, it’s how you deal with it when you do
I will always trust a company more that makes public mistakes, but does the right things to make it right, over a company that has a “perfect” track record
(Ruger fucks up all kinds of shit, but they ALWAYS take care of the customer, so I happily continue to give them money)
Very glad to have purchased and be a dangerous things customer
( and no I’m not equating you to Ruger that’s hurtful)
Could you produce some of the contaminated fluid on purpose?
If you made two vials of fluid, one contaminated, one not, and labeled them A and B, then sent them to Rosco, he could perform a pinprick test on his arm to see if he gets a reaction. If this was the cause of his issues, then his body ought to be sensitized to it and react accordingly. Using two otherwise unmarked fluids would provide a control and keep Rosco in the dark in order to elminate possible observer bias.
Of course, I did just sign Rosco up to be a guinea pig without asking him first, but maybe he’ll forgive me if he gets a confirmation out of this.
I would suggest against. The best way to find out about possible irritants is to check the ingredient list and test for them prioritising the most potent ones. Soy, in this case.
As a rigorous method of finding the specific culpret, you are right. Exhaustively testing every possible contaminent would mean preparing multiple samples, and having Rosco check them all.
I just wanna know if anything in the solution triggers a reaction. Therefore, easy cheaper and potentially more effective to try it all at once.
Would it trigger reaction on you?
Rub it on Rosco! That’s all I can say about it!
The surprising thing about allergy is that anything can cause it. Even water!
You just need to have a large enough group of people as sample.
When I got my implant I was asked about ALL my known allergies. TWICE! Because you never know. Once I had a customer who was allergic to bamboo, I had to cook a new burger, because of one skewer going through the patty. And you’d think bamboo is natural… harmless (unless you watch MythBusters - Chinese Bamboo Torture episode).
I do have the replacement flexM1 that was shipped to me (thanks again @amal and Michelle). It is in the flap seal pouch and all the liquid has now evaporated. However, since I’m in the UK shipping it back and getting a replacement would take some time (not opposed to doing it).
Since, from my understanding, there is a possible layer/coating on the implant that may cause a reaction, could the implant be wiped down with isopropyl/chlorhexidine prior to install?
It will be tacky if you take it out of the package. That is the thin layer of adhesive.
You would need to clean it with either denatured ethanol and a lint free wipes, then soak again in isopropyl and chlorhexidine mix (not the blue shit for skin treatments)… or you can literally wash it with simple fragrance free soap (Ivory or any pure soap) and scrub it gently with fingers … let dry…if still tacky anywhere on the surface keep washing. Once it’s all smooth, soak in isopropyl and chlorhexidine for at least 24 hours.
Of course, you can just send it back and we’ll clean it for you
