BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA LINER

    MDR report key: 2163508 · Received July 7, 2011

    Report

    Report Number
    MW5021296
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    February 28, 2010
    Report Date
    July 7, 2011
    Manufacturer
    OHIO WILLOW WOOD
    Product Code
    IPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA LINER ALPHA LINER IPM OHIO WILLOW WOOD H352-6396

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability