BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 4243285 · Received November 11, 2014

    Report

    Report Number
    2210968-2014-15582
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF FACILITY REPORT #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN (B)(6) 2012. CONCOMITANTLY, THE PATIENT UNDERWENT A CYSTOURETHROSCOPY. THE PATIENT EXPERIENCED VAGINAL PAIN AND IN (B)(6) 2014, THE PHYSICIAN NOTED A SMALL AREA OF EXPOSED MESH IN THE RIGHT VAGINAL FORNIX. THE PATIENT UNDERWENT ANOTHER PROCEDURE DUE TO THE PAIN AND MESH EXPOSURE. IT WAS NOTED THAT THE VAGINAL MESH HAD PARTIALLY ERODED. A PART THE MESH WAS TRIMMED OFF AND SENT TO PATHOLOGY. CURRENTLY, THE PATIENT IS DOING WELL NO PAIN, AND NO COMPLAINTS, NO FURTHER EXPOSED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725900 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3557528

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention