BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 2950438 · Received February 6, 2013

    Report

    Report Number
    3004170064-2013-00022
    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 HAD SURGERY FOR SACROCOLPOPEXY AND FIXATION OF VAGINAL PROLAPSE AND STRESS URINARY INCONTINENCE. THE PRODUCT WAS IMPLANTED ON (B)(6) 2010. AMERICAN MEDICAL SYSTEM'S MONARC DEVICE WAS ALSO IMPLANTED ON THIS DATE. THERE WERE NO COMPLICATION DURING SURGERY. POST-OP THE PT HAD BACKACHE AND WAS TREATED WITH MOTRIN AND PERCOCET. ON (B)(6) 2011, THE PT HAD BLADDER FREQUENCY, VAGINAL PRESSURE AND SOME PROTRUSION AND WAS GIVEN A PESSARY. ON (B)(6) 2011, THE PROLAPSE CUFF HAD HEALED AND THERE WERE NO OTHER ISSUES. ON (B)(6) 2012 THE VAGINA WAS INTACT, THERE WAS RECURRENT PROLAPSE AND NON-SPECIFIC PAIN. 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. LIMITED INFO HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50680 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other