BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3032620 · Received March 29, 2013

    Report

    Report Number
    3004170064-2013-00049
    Event Type
    Other
    Date Received
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. THE PRODUCT WAS IMPLANTED ON (B)(6) 2012. THE DEVICE CATALOG NUMBER PROVIDED, 830-245, IS A VALID CATALOG NUMBER. HOWEVER, THE DEVICE LOT NUMBER PROVIDED, 09091017 IS NOT VALID PRODUCT LOT NUMBER FOR ANY PRODUCT MANUFACTURED BY TEI BIOSCIENCES. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PATIENT SUFFERED AN INJURY (UNSPECIFIED). 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
    130312 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-245 09091017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other