BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 2780379 · Received October 5, 2012

    Report

    Report Number
    1018233-2012-01452
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 7, 2012
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: "PELVISOFT BIOMESH 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 PELVISOFT BIOMESH SHOULD NOT BE USED. PELVISOFT BIOMESH 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 PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM TISSUE SCIENCE LABORATORIES NA 06B14-9

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GYNECARE TVT| PELVISOFT ACELLULAR COLLAGEN BIOMESH| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM