BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOGRAFT (FASCIA LATA)

    MDR report key: 374107 · Received January 23, 2002

    Report

    Report Number
    374107
    Event Type
    Injury
    Date Received
    January 23, 2002
    Date of Event
    December 12, 2001
    Report Date
    January 23, 2002
    Manufacturer
    ALLOSOURCE
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD IMPLANT PERFORMED. RETURNED TO SURGERY. FIFTEEN DAYS LATER FOR I & D - PELVIC ABSCESS. SEEN IN ER DUE TO FEBRILE STATE. RETURNED TO SURGERY ELEVEN DAYS LATER FOR CLOSURE OF VAGINAL MUCOSA. RETURNED FOR REMOVAL OF (DEBRIDEMENT) OF PUBIC SLING (IMPLANT) DUE TO FEBRILE STATE AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOGRAFT (FASCIA LATA) IMPLANT LMO ALLOSOURCE NA 100376038

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention