BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2931183 · Received January 28, 2013

    Report

    Report Number
    2210968-2013-00543
    Event Type
    Injury
    Date Received
    January 28, 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
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY. THE PATIENT UNDERWENT COLONOSCOPY IN 2011 POST IMPLANT.

    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). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE AND LEAKAGE. FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED CHRONIC PELVIC, RECTAL AND VAGINAL PAIN, VAGINAL INFECTIONS, ABNORMAL VAGINAL DISCHARGE WITH ODOR, VAGINAL BLEEDING ABDOMINAL INFLAMMATION. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2010 DUE TO PAIN AND VAGINAL COMPLICATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT EXPERIENCED URETHRAL DISCOMFORT AND UNDERWENT EXCISION OF EXPOSED MESH ON (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL (B)(4) PATIENT CODES: (B)(4) - INTRINSIC SPHINCTER DEFICIENCY; (B)(4) - INCONTINENCE ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 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
    37040 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1396005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention