BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 3445677 · Received October 31, 2013

    Report

    Report Number
    1018233-2013-08978
    Event Type
    Injury
    Date Received
    October 31, 2013
    Report Date
    October 1, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    PAI
    PMA / PMN Number
    K031332
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. 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. (B)(4).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559740 PELVISOFT ACELLULAR COLLAGEN BIOMESH PAI TISSUE SCIENCE LABORATORIES NA 08B12-9

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention