BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972301 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01508
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS INCONTINENCE, UTERINE PROLAPSE, CYSTOCELE, VAGINAL VAULT PROLAPSED AND LEFT LOWER QUADRANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A LAVH, ANTERIOR REPAIR, UTEROSACRAL VAULT SUSPENSION, LYSIS OF OMENTAL ADHESIONS, AND CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT REPORTED ¿MY BLADDER STILL LEAKS, DO NOT HAVE ORGASMS ANYMORE, SHARP ABDOMINAL PAIN ON A REGULAR BASIS, HAVE TO WIPE BEFORE I CAN URINATE AND PAIN WITH INTERCOURSE¿. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010 DUE TO MESH EROSION CAUSING PAIN, DISCOMFORT AND INABILITY TO DO SPORTS OR HAVE SEXUAL ACTIVITY. IT WAS REPORTED ON (B)(6) 2010, A 1 CM BY 0.5 CM PORTION OF MESH WAS REMOVED, FOLLOWED BY A FEW INDIVIDUAL STRANDS. SMALL MESH EXPOSURE TO R OF URETHRA APPROX 1 CM, NO PUS. (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) 2009 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75571 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3256664

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention