BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3033505 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03250
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBTURATOR SLING PROCEDURE ON 08/23/2007. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN ON THE RIGHT SIDE DUE TO AN EROSION ON THAT SIDE. THE PATIENT UNDERWENT A SMALL PROCEDURE FOR TREATMENT OF THE EROSION WHICH HAD NO EFFECT ON THE PATIENT¿S PAIN. THE PHYSICIAN REMOVED AS MUCH OF THE SLING AS POSSIBLE BETWEEN THE RAMI INFERIOR AND OSSIS PUBIS, ESTIMATED APPROXIMATELY 5 CM. CURRENTLY, THERE IS NO MESH EROSION. THE MESH SLING IS SUPERFICIALLY JUST UNDER THE LINING OF MUCOSA RIGHT SIDE. CURRENTLY, THE PATIENT REPORTED THAT HER PAIN IS GONE, HAS RESUMED ALL PHYSICAL ACTIVITIES INCLUDING SEXUAL ACTIVITY WITHOUT PAIN. SHE HAD AN URGE COMPONENT WHICH IS ALSO IMPROVED, BUT STILL HAS STRESS URINARY INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBTURATOR SLING PROCEDURE ON (B)(6) 2012. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN ON THE RIGHT SIDE DUE TO EROSION. THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136581 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3021273

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention