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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.

Bob Burnett
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.

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