BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2932755 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00644
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, A SYMPTOMATIC CYSTOCELE, URINE LEAKAGE, MILD INTRINSIC SPHINCTER DISABILITY, AND URETHRAL HYPERMOBILITY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED NOCTURIA, BLOOD AND BACTERIA IN URINE, RECURRENT URINARY TRACT INFECTIONS, HIP PAIN, LOWER BACK PAIN, KIDNEY INFECTIONS, VAGINAL AND PELVIC PAIN, INSOMNIA, CONSTIPATION, AND ABDOMINAL BLOATING. THE PATIENT IS CONSTANTLY WET AND UNCOMFORTABLE FROM URINE LEAKAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCOMPLETE EMPTYING OF BLADDER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCOMPLETE EMPTYING OF BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39061 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2990109

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention