BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2800254 · Received October 22, 2012

    Report

    Report Number
    2210968-2012-06768
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    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

    (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 FOUR MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06769 , 2210968-2012-06767 AND 2210968-2012-06765. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DUE TO PELVIC AND VAGINAL PAIN, URINARY DISTURBANCES, STRESS URINARY INCONTINENCE AND MESH EROSION THE PATIENT UNDERWENT MESH REMOVAL/REVISION ON (B)(6) 2008, (B)(6) 2010 AND (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY RETENTION AND VAGINAL TENDERNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3068168

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention