BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2760458 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05561
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE AND A SLING WAS IMPLANTED. IT WAS REPORTED THAT AFTER IMPLANTATION PATIENT EXPERIENCED PAIN, INFECTION, BLEEDING, DYSPAREUNIA AND URINARY, BOWEL AND NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL MESH EXCISION OF ERODED GENITOURINARY IMPLANT, URETHROLYSIS AND CYSTOURETHROSCOPY ON (B)(6) 2012 BECAUSE OF PAIN DUE TO CONSISTENT INFECTIONS. IT WAS FURTHER REPORTED THAT THE PATIENT ON (B)(6) 2012 UNDERWENT A CYSTOSCOPY DUE TO CHRONIC HEMATURIA AND INCONTINENCE. (B)(4) - URINARY/BOWEL PROBLEMS; DYSPAREUNIA. 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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY FREQUENCY, URGE INCONTINENCE, DIFFICULTY EMPTYING HER BLADDER AND DISCOMFORT ON THE LOWER ABDOMEN. (B)(4).

    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 FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY FREQUENCY, URGE INCONTINENCE, DIFFICULTY EMPTYING HER BLADDER AND DISCOMFORT ON THE LOWER ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2913683

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention