BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3935874 · Received June 26, 2014

    Report

    Report Number
    3004170064-2014-00141
    Event Type
    Other
    Date Received
    June 26, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 26, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    Description of Event or Problem · 1

    THIS IS BEING REPORTED AS AN ADVERSE THAT OCCURRED AS PART OF THE FDA 522 ORDER POST-MARKET SURVEILLANCE STUDY. THE PATIENT HAD SURGERY SCHEDULED TO UNDERGO PELVIC FLOOR REPAIR (VAGINAL APPROACH) HYSTEROPEXY INCLUDING CYSTOCELE REPAIR AND A TRANSOBTURATOR MID-URETHRAL SLING PROCEDURE. ONE DEVICE WAS IMPLANTED ON (B)(6) 2014 ALONG WITH A MID-URETHRAL SLING (NOT IDENTIFIED) WITHOUT COMPLICATIONS. ON (B)(6) 2014 THE PATIENT EXPERIENCED DIFFICULTY EMPTYING HER BLADDER. THE PHYSICIAN PRESCRIBED VALIUM AND INSERTED A FOLEY CATHETER. THE EVENT WAS OF MODERATE SEVERITY. THE EVENT RESOLUTION IS CURRENTLY UNKNOWN. THE PHYSICIAN ASSESSED THE EVENT AS PELVIC FLOOR RELATED AND PROBABLY RELATED TO THE DEVICE. (THE DEVICE WAS NOT SPECIFIED.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374330 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-247 1402016

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention