BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3122265 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05717
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05716. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AT THE TIME OF MESH IMPLANTATION THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF TRANSVAGINAL TAPE OBTURATOR URETHROPEXY, ANTERIOR COLPORRHAPHY, ANTERIOR MESH PLACEMENT, AND POSTERIOR MESH PLACEMENT. IT WAS REPORTED THAT THE MESH WAS IMPLANTED ¿IN A HAMMOCK FASHION¿ BUT THEN ¿PULLED OUT IN THE PROCESS OF REMOVING THE CANNULA¿, THEREFORE THEY ¿HAD TO GO BACK AND DO A MESH IN A USUAL FASHION¿. (PER DESCRIPTION OF PROCEDURE). THIS MESH IS NOTED ON RECORD AS ¿IN & OUT¿.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A SACROSPINOUS SUSPENSION AND ANTERIOR COLPORRHAPHY DUE TO INCONTINENCE AND VAGINAL VAULT PROLAPSE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PELVIC PAIN, VAGINAL PRESSURE, DYSPAREUNIA, VAGINAL SCARRING, VAGINAL PAIN, INCONTINENCE AND BACK PAIN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224414 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2926971

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention