BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2961060 · Received February 14, 2013

    Report

    Report Number
    2210968-2013-01137
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2011. IN THE SUMMER OF 2012, THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS. THE PATIENT EXPERIENCED OCCASIONAL SHARP PAIN UNDER AREA OF LEFT ABDOMINAL WALL INCISION SITE. THE PAIN WORSENED WITH VARIOUS MOVEMENTS AND WAS ONLY RELIEVED WITH REST. ON (B)(6) 2012, THE PATIENT UNDERWENT AN EXAMINATION UNDER ANESTHESIA AND THIN TISSUE IN THE VAGINAL AREA OVER MESH WAS NOTED, BUT NO EXPOSED MESH. A VAGINAL FLAP WAS CREATED TO PLACE THE MESH DEEPER IN THE TISSUE. ON (B)(6) 2013, A REPEAT UDN WAS PERFORMED AND WAS NORMAL WITH RESOLUTION OF STRESS INCONTINENCE. THERE WERE NO APPRECIABLE BLADDER CONTRACTIONS. PHYSICAL THERAPY IS NOW PLANNED FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64809 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3545717

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention