BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 2950439 · Received February 6, 2013

    Report

    Report Number
    3004170064-2013-00023
    Event Type
    Other
    Date Received
    February 6, 2013
    Report Date
    February 4, 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 PRODUCT LOT NUMBER WAS 070432. THE EXPIRATION DATE WAS 03/31/2010. THE PRODUCT LOT 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. THE PRODUCT WAS IMPLANTED ON (B)(6) 2007. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PT SUFFERED AN INJURY (UNSPECIFIED). IT IS NOT KNOWN WHEN THE EVENT OCCURRED. IT IS NOT KNOW 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
    50196 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-243 070432

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other