BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3313733 · Received August 19, 2013

    Report

    Report Number
    3004170064-2013-00278
    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 830-247. THE DEVICE LOT NUMBER WAS 0802003. 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) 2008. ETHICON'S TVT SECURE DEVICE WAS ALSO IMPLANTED AT THIS TIME. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PATIENT SUFFERED AN 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
    400165 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-247 0802003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other