BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 3060157 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01135
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    TISSUE SCIENCE LABS.
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATION 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: "PELVISOFTTM BIOMESH IS FOR SINGLE-PT 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 PELVISOFTTM BIOMESH SHOULD NOT BE USED. PELVISOFTTM 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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-01134 AND 1018233-2013-01268.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156303 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM TISSUE SCIENCE LABS. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention URETEX TO2 URETHRAL SUPPORT SYSTEM| PELVISOFT ACELLULAR COLLAGEN BIOMESH