InjuryIPM
ALPHA LINER
Received Jul 7, 2011 · Event occurred Feb 28, 2010
Report MW5021296 · MDR key 2163508
Device
Product problems
- Hole In Material
- Defective Device
Patient
40 YR
- Ulcer
Narrative
Description of Event or Problem
I AM AN AMPUTEE THAT WAS FITTED WITH 2 FAULTY LINERS PRODUCED BY (B)(4). THESE LINERS ARE DISTRIBUTED BY (B)(4). THE LINERS ARE THIN IN THE FRONT AND DEVELOPED A SMALL HOLE WHICH CAUSED AN ULCER IN MY STUMP. I WAS TREATED BY THE BURN WOUND CENTER AT (B)(6) HOSPITAL. AT THIS TIME, I STILL CANNOT USE MY PROSTHETIC FULL TIME. THIS INJURY ALMOST CAUSED ME TO GET AN ABOVE THE KNEE AMPUTATION. (B)(4) CLAIMS THEY ARE NOT AT FAULT. TWO OTHER AMPUTEES HAVE SUFFERED THE SAME INJURIES DUE TO HE SAME LINERS. DATES OF USE: (B)(6) 2011. NEVER HAD THERAPY.