BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PELVICOL ACCELULAR COLLAGEN MATRIX

    MDR report key: 2033404 · Received March 24, 2011

    Report

    Report Number
    1018233-2011-00049
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 22, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTED TO THE REPORTED ISSUE. 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." (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 SIGNIFICANT MENTAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY AND PERMANENT AND SUBSTANTIAL DEFORMITY, AND UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PELVICOL ACCELULAR COLLAGEN MATRIX FTL C.R. BARD, INC. NA 06B10-3

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention