BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 1920139 · Received December 8, 2010

    Report

    Report Number
    1018233-2010-00136
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE DEVICE REMAINS IMPLANTED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES "USE OF THE MESH IS CONTRAINDICATED FOR PATIENTS EXPERIENCING ANY OF THE FOLLOWING CONDITIONS: PREGNANCY, URINARY TRACT INFECTION, ANTICOAGULANT THERAPY, AND/OR INFECTION IN THE OPERATIVE FIELD". IN THE PRECAUTIONS SECTION, IT STATES "THE MESH IS FOR SINGLE-PT USE ONLY AND IS TO BE IMPLANTED SURGICALLY. IF EITHER THE OUTER POLYESTER/POLYETHYLENE POUCH OR THE INNER FOIL POUCH HAS BEEN PERFORATED OR TORN IN SHIPMENT OR STORAGE, THEN THE ENCLOSED MESH SHOULD NOT BE USED. THE MESH SHOULD BE HYDRATED OR MOIST WHEN THE PACKAGE IS OPENED. DEHYDRATED OR DRY TISSUE SHOULD NOT BE IMPLANTED". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE MESH IMPLANTED, THE PT HAS EXPERIENCED SERIOUS BODILY INJURIES INCLUDING EXTREME PAIN, INFECTION OF HER BODILY TISSUES, DYSPAREUNIA, SIGNIFICANT MENTAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURIES, AND HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention