BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2850527 · Received November 29, 2012

    Report

    Report Number
    2210968-2012-07574
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100485
    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): IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT CYTOSCOPY DUE TO STRESS URINARY INCONTINENCE. FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL PAIN, SEVERE BLADDER SPASMS, RECURRENT URINARY INCONTINENCE, SEVERE URGENCY AND FREQUENCY, INTERSTITIAL CYSTITIS, DYSPAREUNIA, AND SHARP ABDOMINAL AND VAGINAL PAINS. ON (B)(6) 2011 THE PATIENT WAS EXPERIENCING STRESS URINARY INCONTINENCE. SHE HAD A ¿BLADDER LIFT¿ FIFTEEN YEARS AGO ¿ STITCHES PROTRUDING ¿ REDONE RIGHT AFTER. [AS WRITTEN]. THE PATIENT UNDERWENT A MODIFIED PEREYRA/BLADDER SUSPENSION, PUBO VAGINAL SLING [PRODUCT NOT IDENTIFIED], ANTERIOR VAGINAL WALL SLING, [PRODUCT NOT IDENTIFIED], PARAVAGINAL REPAIR, BIRCH BLADDER SUSPENSION AND UTEROSACRAL LIGAMENT PLICATION ON (B)(6) 2001. THE PATIENT EXPERIENCED SUTURE EROSION VAGINALLY FROM PREVIOUS VAGINAL WALL SLING [PRODUCT NOT IDENTIFIED]. SHE HAD PELVIC PAIN AND UNDERWENT ¿EXPLORATORY LAPAROTOMY WITH LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO-OOPHORECTOMY, COAGULATION OF ENDOMETRIOSIS, VAGINOPLASTY WITH SLING BURIAL¿ ON (B)(6) 2001. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3552986

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention