BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 2894131 · Received December 27, 2012

    Report

    Report Number
    1018233-2012-02179
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    October 12, 2015
    Manufacturer
    TISSUE SCIENCE LABS
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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. 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

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED CHRONIC PAIN, EXCESSIVE BLEEDING, INFECTION, HARDENING, MESH EROSION, EROSION AND DESTRUCTION OF VAGINAL TISSUE, SEVERE AND PERMANENT BODILY INJURIES AND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTM TISSUE SCIENCE LABS NA 08B22-9

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention CALDERA DESARA SLING| CALDERA MEDICAL DESERA| PROLENE MESH SXS| PROLENE MESH SXS| CALDERA DESARA SLING