BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 3231648 · Received July 12, 2013

    Report

    Report Number
    1018233-2013-02813
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECS 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 ADVERSE REACTIONS: "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

    COMPLAINT # (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR #S 1018233-2013-02811 AND 02812.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321927 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM TISSUE SCIENCE LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention PELVISOFT ACELLULAR COLLAGEN BIOMESH:| PRODUCT # 481047, LOT # UNK, EXP DATE UNK, (X2)