inforMED
InjuryIPM

ALPHA LINER

Received Jul 7, 2011 · Event occurred Feb 28, 2010

Report MW5021296 · MDR key 2163508

Device

Generic name

Alpha Liner

Manufacturer

Ohio Willow Wood

Lot number

H352-6396

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.