BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3004661493-2006-00007

    MDR report key: 3068361 · Received November 9, 2006

    Report

    Report Number
    3004661493-2006-00007
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 9, 2006
    Manufacturer
    MAST BIOSURGERY USA INC.
    Product Code
    FTL
    PMA / PMN Number
    K050332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LAPAROSCOPIC HYSTERECTOMY (B)(6) 2006. SURGI-WRAP WAS PLACED TO PREVENT ADHESIONS. THIS ERODED INTO THE VAGINA AND LACERATED HER PARTNER. THIS WAS REMOVED AT EXPL LAP (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FTL MAST BIOSURGERY USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization