BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 2063703 · Received April 13, 2011

    Report

    Report Number
    1018233-2011-00069
    Event Type
    Injury
    Date Received
    April 13, 2011
    Report Date
    December 18, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. 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-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 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 PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT(S) IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM C.R. BARD, INC. NA 07B04-1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention ALIGN URETHRAL SUPPORT SYSTEM| AVAULTA SOLO ANTERIOR SUPPORT SYSTEM| AVAULTA SOLO ANTERIOR SUPPORT SYSTEM