[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]
Re: [IP] Silhouette complaint
MiniMed filed a 510(k) back in July 99 for a "Quick Serter Infusion Set
Inserter System Model 395". According to the documentation, it's
"specifically designed for use with the Maersk Medical A/S Contour Infusion
Sets. The device is contraindicated for use with other infusion sets."
I've heard nothing further on this, nor have I heard anything about the
"Contour" infusion sets. A WAG has me thinking that this device / infusion
set may be a result of some feedback re: a tool to help insert Silhouette /
Tender / Comfort sets. I doubted they would be able to safely "jab" the
long insertion needle from the Silhouette, so it's possible they (Maersk)
designed a new set.
I'm surprised we haven't heard anything about this. Perhaps MM is waiting
for the excitement of the 508 to subside a bit before they announce this.
mailto:email @ redacted
At 11:32 AM 10/13/99 -0800, you wrote:
>I realized that what I don't like about Silhouettes is that the hole
>where the cannula goes into your skin is wide open to the air and water
>-- the cannula goes through a hole in the plastic and straight into your
>It seems to me that this is just a free ticket to infection -- and I
>have had a couple of little infections with the Silhouettes, but none
>with the SofSets.
>So if I was going to ask for a new set design, it would be for a
>sideways-inserting set that was sealed from the exterior -- I can
>actually see how it could be done, so why aren't they doing it??
>I'm gonna mention it to the MM rep tonight.
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
send a DONATION http://www.Insulin-Pumpers.org/donate.shtml