BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 2925124 · Received January 17, 2013

    Report

    Report Number
    1018233-2012-02197
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    October 29, 2015
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE AS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPEC 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-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 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

    THIS MDR IS BEING FILED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PT'S ATTORNEY IN MDR# 1018233-2012-02195, 02198, AND 02196. THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PT'S MEDICAL RECORDS. ASSOCIATED MDRS: 1018233-2012-02195, 02198, 02196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26940 PELVISOFT ACELLULAR COLLAGEN BIOMESH Mesh, surgical FTM TISSUE SCIENCE LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM| AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| ALIGN TO URETHRAL SUPPORT SYSTEM| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM