BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFORCE GRAFT

    MDR report key: 3963518 · Received July 24, 2014

    Report

    Report Number
    MW5037458
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    December 19, 2013
    Report Date
    July 24, 2014
    Manufacturer
    INTEGRA
    Product Code
    FTM
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A TENDON REPAIR SURGERY ON (B)(6) 2013. FOUND OUT ON (B)(6) 2014 THE INFORCE REINFORCEMENT MATRIX THAT WAS USED HAD EXPIRED IN OCTOBER. ON (B)(6), HAD TO HAVE A DEBRIDEMENT PREFORMED DUE TO INFECTION. WHICH HAS LED TO KNOW HAVING NO TENDON IN FOOT. STILL UNDER DOCTORS CARE ISSUES WITH SWELLING, HEALING. NO ONE WILL SAY IF THE INFORCE BEING EXPIRED CAUSED THIS PROBLEM, BUT NO ONE CAN STATE IT DID NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434878 INFORCE GRAFT INFORCE GRAFT FTM INTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization