BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 826545 · Received March 6, 2007

    Report

    Report Number
    MW1042116
    Event Type
    Injury
    Date Received
    March 6, 2007
    Date of Event
    November 1, 2005
    Report Date
    February 25, 2007
    Manufacturer
    *
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FEMALE WAS REFERRED TO THE ORTHOPEDIC ONCOLOGY SERVICE BY HER PRIMARY PHYSICIAN WITH COMPLAINTS OF PERSISTENT PAIN AND A LEFT MEDIAL THIGH MASS ONE YR AFTER AN OBTAPE TRANSOBTURATOR SLING PROCEDURE (MENTOR CORP.) FOR STRESS URINARY INCONTINENCE. SIX MONTHS AFTER THE PROCEDURE, SHE FELT TIGHTNESS IN THE VAGINA, DYSPAREUNIA, AND NOTED A BULGE IN HER MEDIAL THIGH. MULTIPLE MUSCLE BIOPSIES OF THE ENLARGING MASS WERE INCONCLUSIVE, RAISING CONCERN FOR INFLAMMATORY SARCOMA. INCISION AND DRAINAGE FOR PERSISTENT PAIN FINALLY ESTABLISHED THE PRESENCE OF A THIGH ABSCESS. AFTER INTRAVENOUS ANTIBIOTICS, WOUND VACUUM, AND MULTIPLE WOUND DEBRIDEMENTS, SLING MATERIAL WAS FOUND IN THE OBTURATOR SPACE REVEALING THE THIGH ABSCESS AS A COMPLICATION OF THE TRANSOBTURATOR SLING. THE PT WAS REFERRED TO UROGYNECOLOGY FOR EVALUATION AND EXCISION OF THE SLING. PRE-OPERATIVE CIPROFLOXACIN AND METRONIDAZOLE WERE GIVEN, AND COPIOUS IRRIGATION WAS PERFORMED OF THE ANTERIOR VAGINA. EXAMINATION UNDER ANESTHESIA REVEALED EXPOSED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTAPE TRANSOBTURATOR SLING * FTL * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R