BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2934188 · Received January 30, 2013

    Report

    Report Number
    2210968-2013-00660
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE DURING A HYSTERECTOMY ON (B)(6) 2001. POST OPERATIVELY, THE PATIENT BLED AROUND HER BLADDER AREA FOR AN UNKNOWN SPORADIC AMOUNT OF TIME ACCOMPANIED BY EXTREME PAIN. THE PATIENT ALSO REPORTED IT WAS EXTREMEMELY PAINFUL TO URINATE. THIS WENT ON FOR YEARS. THE PATIENT NO LONGER HAS PAIN OR BLEEDING, BUT AT TIMES THE SYMPTOMS DO COME AND GO. THE PATIENT WAS SEEN BY MANY DOCTORS WHO PRESCRIBED ANTIBIOTICS ONLY, THEY WERE UNABLE TO HELP HER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40787 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention