BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3850993 · Received May 22, 2014

    Report

    Report Number
    3004170064-2014-00122
    Event Type
    Other
    Date Received
    May 22, 2014
    Report Date
    May 22, 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 LOT NUMBER PROVIDED WAS 060414 WITH A PART NUMBER OF 830-247. THE LOT NUMBER DID NOT CORRESPOND TO A XENFORM DEVICE LOT NUMBER. HOWEVER, THE DEVICE LOT NUMBER WAS PROBABLY 0804014 WITH A CORRESPONDING PART NUMBER OF 830-247. THIS DEVICE HISTORY RECORD 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 PT WAS ORIGINALLY TREATED FOR. ONE DEVICE WAS IMPLANTED ON (B)(6) 2008. NO ADDITIONAL INFO WAS PROVIDED. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PT SUFFERED AN INJURY (UNSPECIFIED). IT IS NOT KNOWN WHEN THE EVENT OCCURRED. IT IS NOT KNOWN WHAT THE PT'S CURRENT CONDITION IS. NO INFO HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306712 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-247 080414

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other