BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 2896451 · Received December 28, 2012

    Report

    Report Number
    1018233-2012-02177
    Event Type
    Injury
    Date Received
    December 28, 2012
    Report Date
    November 28, 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
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. WHEN IT IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDR'S: 1018233-2012-02176 AND 02178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM TISSUE SCIENCE LABORATORIES NA 08B03-9

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PELVISOFT ACCELLULAR COLLAGEN BIOMESH