BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2982717 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01837
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE STRESS URINARY INCONTINENCE AND CYSTOCELE. ON (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL BLEEDING AND CLOSURE OF VAGINAL WALL POSSIBLY RELATED TO MESH EXPOSURE. ON (B)(6) 2008, THE PATIENT UNDERWENT RECLOSURE OF VAGINAL WALL, EXCISION OF ANTERIOR MESH, AND VAGINAL GRAFT INLAY: COOK SURGISS VAGINAL GRAFT. ON (B)(6) 2011, THE PATIENT UNDERWENT REMOVAL OF MESH AND CYSTOCELE. ON (B)(6) 2012, THE PATIENT UNDERWENT BLADDER RECONSTRUCTION WITH FASCIA HAMMOCK.

    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 2210968-2013-01835. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, UTIS AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86813 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3128456

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention