BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2870416 · Received December 12, 2012

    Report

    Report Number
    2210968-2012-08071
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC PROLAPSE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF A HYSTERECTOMY DURING MESH IMPLANTATION. IT WAS REPORTED THAT AFTER IMPLANTATION THE PATIENT EXPERIENCED PAIN, URINARY AND BOWEL PROBLEMS. IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT CONTINUED TO HAVE URINARY INCONTINENCE AND NOCTURIA AND WILL UNDERGO ADDITIONAL TESTING AS THE DIFFERENTIAL DIAGNOSIS IS A VESICO-URETHRAL OR URETHRAL VAGINAL FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT URINARY RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3238459

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention