BEUDAMED
    FDA Adverse Event Summary report: N

    PELVISOFT ACELLULAR COLLOGEN BIOMESH

    MDR report key: 3010483 · Received March 14, 2013

    Report

    Report Number
    1018233-2013-00722
    Date Received
    March 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTM
    PMA / PMN Number
    K031332
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET AL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESS POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: "PELVISOFT BIOMESH IS FOR SINGLE PATIENT 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 PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, INJURY, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-00720 AND 1018233-2013-00721.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108398 PELVISOFT ACELLULAR COLLOGEN BIOMESH FTM TISSUE SCIENCE LABORATORIES NA 08B11-9

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention PELVISOFT ACELLULAR COLLAGEN BIOMESH| PELVILACE BIOURETHRAL SUPPORT SYSTEM