BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3993735 · Received July 8, 2014

    Report

    Report Number
    3004170064-2014-00177
    Event Type
    Other
    Date Received
    July 8, 2014
    Report Date
    July 25, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    Description of Event or Problem · 1

    THIS IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE COMPLAINT ORIGINATED FROM AN ATTORNEY. IT IS NOT KNOWN WHAT THE PATIENT WAS ORIGINALLY TREATED FOR. ONE DEVICE WAS IMPLANTED ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PATIENT SUFFERED AN INJURY INCLUDING EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC NERVE DAMAGE, ACUTE AND CHRONIC NERVE PAIN, ADDITIONAL SURGICAL PROCEDURES. IT IS NOT KNOWN WHEN THE EVENT OCCURRED. IT IS NOT KNOWN WHAT THE PATIENT'S CURRENT CONDITION IS. NO INFORMATION HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398287 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-241 0905001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other