BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3122445 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05730
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AN OBTURATOR SLING PROCEDURE ON (B)(6) 2009. THREE TO FOUR WEEKS POST OPERATIVELY, THE PATIENT HAD PAIN IN THE VAGINAL AREA WHEN WALKING AND MOVING. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2010. THREE TO FOUR WEEKS AFTER THE REVISION, SHE STATED THE REVISION DID NOT WORK. THE PATIENT REPORTED THAT IN 2010, THE MESH WAS REMOVED AND SHE HAD A MARSHAL-MARCHETTI BLADDER PROCEDURE. THE PATIENT STATED THAT THREE TO FOUR MONTHS AFTER THAT PROCEDURE, SHE RIPPED OUT THE SUSPENSION AND THEN DEVELOPED STRESS INCONTINENCE. THE PATIENT HAS BEEN SEEN BY ANOTHER PHYSICIAN WHO WANTS TO DO A FOURTH PROCEDURE WITH A SLING, BUT THAT SHE IS UNSURE IF SHE WANTS ANOTHER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224662 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention