BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3935910 · Received June 26, 2014

    Report

    Report Number
    3004170064-2014-00133
    Event Type
    Other
    Date Received
    June 26, 2014
    Date of Event
    May 27, 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 EVENT THAT OCCURRED AS PART OF THE (B)(4) STUDY. THE PT HAD SURGERY SCHEDULED TO UNDERGO PELVIC FLOOR REPAIR INCLUDING APICAL VAULT SUSPENSION, CYSTOCELE REPAIR AND A TRANSOBTURATOR MID-URETHRAL SLING PROCEDURE. ONE DEVICE WAS IMPLANTED ON (B)(6) 2014 ALONG WITH A TRANSOBTURATOR SLING (NOT IDENTIFIED) WITHOUT COMPLICATIONS. ON (B)(6) 2014 THE PT PRESENTED WITH VAGINAL WALL DEHISCENCE OF GREATER THAN 1 CM AT THE VAGINAL SUTURE LINE. THE PHYSICIAN PRESCRIBED DOXYCYCLINE, VINEGAR DOUCHE AND REST. THE EVENT WAS OF MODERATE SEVERITY AND IS CURRENTLY RESOLVING. THE PHYSICIAN ASSESSED THE EVENT AS PELVIC FLOOR RELATED; DEFINITELY RELATED TO THE INDEX PROCEDURE AND DEFINITELY RELATED TO THE DEVICE. (THE DEVICE WAS NOT SPECIFIED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374785 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-247 1308016

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention