BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3313730 · Received August 19, 2013

    Report

    Report Number
    3004170064-2013-00273
    Event Type
    Other
    Date Received
    August 19, 2013
    Report Date
    August 19, 2013
    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 PART NUMBER WAS NOT PROVIDED, HOWEVER, THE DEVICE LOT NUMBER WAS PROVIDED AND WAS 0704032. THE DEVICE PART NUMBER WAS DETERMINED TO BE 830-241. THE DEVICE HISTORY RECORD FOR THE 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) 2007. BOSTON SCIENTIFIC'S ADVANTAGE DEVICE WAS ALSO IMPLANTED ON THIS DATE. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PATIENT SUFFERED AN UNSPECIFIED INJURY. 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
    399851 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-241 0704032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other