BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM SURGICAL MESH

    MDR report key: 2950433 · Received February 6, 2013

    Report

    Report Number
    3004170064-2013-00016
    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

    Description of Event or Problem · 1

    THIS IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE COMPLAINT ORIGINATED FROM AN ATTORNEY. THE PT WAS BEING TREATED FOR AN ANTERIOR REPAIR OF PELVIC ORGAN PROLAPSE. THE PRODUCT WAS IMPLANTED ON (B)(6) 2010. BOSTON SCIENTIFIC'S ADVANTAGE DEVICE WAS ALSO IMPLANTED ON THIS DATE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. ON A (B)(6) 2010 VISIT, THE PT COMPLAINED OF URINARY RETENTION. ON A (B)(6) 2010 PHONE CALL, THE PT COMPLAINED OF RECTAL PAIN. ON A (B)(6) 2010 VISIT, THE PT COMPLAINED OF RECTAL PAIN AND WAS PRESCRIBED LORTAB AND STOOL SOFTENER. ON (B)(6) 2012, THERE WERE NO ISSUES REPORTED. 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
    50258 XENFORM SURGICAL MESH TEI BIOSCIENCES NC. FTM TEI BIOSCIENCES INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other