ICEROSS SEAL-IN V 34
Received Oct 17, 2016 · Event occurred Sep 15, 2016
Report 3003764610-2016-00007 · MDR key 6033583
Device
Generic name
Silicone Prosthetic Liner
Manufacturer
Ossur IcelandModel number
I-471334Catalog number
I-471334
Lot number
HF160725
Product problems
- Device Slipped
Patient
48 YR
- Fall
- Tissue Damage
- Fall
- Tissue Damage
Narrative
Description of Event or Problem
A BELOW KNEE AMPUTEE PATIENT WEARING THE ICEROSS SEAL IN V 34 PRODUCT SPENT SEVERAL HOURS IN A PUB WHERE HE SAT FOR ABOUT TWO HOURS. AS HE GOT UP, THE SOCKET OF THE STUMP SLIPPED. THE LINER REMAINED AT THE STUMP. HE AND A GLASS BOTH FELL TO THE GROUND WHERE HE INJURED HIS HAND ON THE BROKEN GLASS AND LOST A PART OF HIS FINGER. THE PATIENT SPENT A WEEK IN THE HOSPITAL AND HAD HIS FINGER TIP REATTACHED. THE PATIENT LOST HIS FINGER NAIL.
Description of Event or Problem
A BELOW KNEE AMPUTEE PATIENT WEARING THE ICEROSS SEAL IN V 34 PRODUCT SPENT SEVERAL HOURS IN A PUB WHERE HE SAT FOR ABOUT TWO HOURS. AS HE GOT UP, THE SOCKET OF THE STUMP SLIPPED. THE LINER REMAINED AT THE STUMP. HE AND A GLASS BOTH FELL TO THE GROUND WHERE HE INJURED HIS HAND ON THE BROKEN GLASS AND LOST A PART OF HIS FINGER. THE PATIENT SPENT A WEEK IN THE HOSPITAL AND HAD HIS FINGER TIP REATTACHED. THE PATIENT LOST HIS FINGER NAIL.