BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2933014 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00618
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT AFTER IMPLANTATION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, DYSPAREUNIA, URINARY INCONTINENCE, RETENTION AND LEAKAGE, NUMEROUS URINARY AND VAGINAL INFECTIONS, VAGINAL DISCHARGE AND ABNORMAL BOWEL MOVEMENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2008. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. (B)(4). DYSPAREUNIA. LEAKAGE. ABNORMAL BOWEL MOVEMENT.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/26/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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
    39673 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3038189

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention