BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 2926411 · Received January 15, 2013

    Report

    Report Number
    3004170064-2013-00004
    Event Type
    Other
    Date Received
    January 15, 2013
    Report Date
    January 15, 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) 2008. ETHICON¿S GYNEMESH WAS ALSO IMPLANTED AT THIS TIME. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT REPORTED PELVIC ACHING TWO (2) WEEKS POST-OP AND WAS GIVEN BACTRIM-DS. DURING THE PATIENT¿S LAST VISIT ON (B)(6) 2010, IT WAS REPORTED THAT THERE WAS SOME BURNING INTERCOURSE, ATROPHY CHANGES AND LYCHEN SCLEROSIS AND WAS GIVEN PREMARIN AND CLOBETASOL CREAMS. 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 INFO HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21804 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other