BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL

    MDR report key: 1910955 · Received November 23, 2010

    Report

    Report Number
    1018233-2010-00121
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    October 29, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THE DEVICE REMAINS IMPLANTED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN PRECAUTIONS SECTION: "IMPLANT IS FOR SINGLE-PATIENT 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 IMPLANT SHOULD NOT BE USED." IT ALSO STATES: "DO NOT USE TISSUE IF EITHER INNER OR OUTER POUCH IS PUNCTURED, TORN, OR NOT INTACT." PATIENT (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 PATIENT HAS EXPERIENCED SERIOUS BODILY INJURIES INCLUDING EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUE, DYSPAREUNIA, SIGNIFICANT MENTAL PAIN AND SUFFERING, UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES, AND SHE HAS SUSTAINED PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL FTL C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention