BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972511 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01498
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 31, 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 2210968-2013-01499. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND VAGINAL PROLAPSE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH INSERTION OF BIOLOGICAL GRAFT X2, CYSTOSCOPY, AND VAGINAL EXTRAPERITONEAL COLPOPEXY; DUE TO WEAKENED RUBOVAGINAL AND RECTOVAGINAL FASCIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION AND EXCISION OF VAGINAL FOREIGN BODY WITH REMOVAL OF PERMANENT SUTURE AND FEW FIBERS OF MESH GRAFT, AND DIAGNOSTIC CYSTOSCOPY ON (B)(6) 2012 DUE TO VAGINAL BLEEDING WITH EXPOSED VAGINAL FOREIGN BODY AND URINARY FREQUENCY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT 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
    76812 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3405426

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention