BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972691 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01578
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01580. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STAGE 2 ANTERIOR PROLAPSE, STAGE 1 POSTERIOR PROLAPSE, PELVIC PRESSURE/PAIN, DYSFUNCTIONAL UTERINE BLEEDING, STRESS URINARY INCONTINENCE AND A SLING WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT A CYSTOSCOPY AND PARTIAL HYSTERECTOMY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SEVERE PAIN, PELVIC PAIN, PAIN WHILE WALKING, DIFFICULTY DURING INTERCOURSE, DYSPAREUNIA, CONSTIPATION AND MENTAL AND EMOTIONAL DAMAGES. IT WAS REPORTED THAT PATIENT UNDERWENT ADDITIONAL SURGERY: (B)(6) 2010 :LAPAROSCOPY, SCAR TISSUE REMOVAL, UNTANGLE OVARY (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL WALL SLING AND CYSTOSCOPY ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO PAIN, DYSPAREUNIA, AND PARTIAL EROSION OF SLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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 THE PATIENT UNDERWENT EXCISION OF VAGINAL WALL SLING AND CYSTOSCOPY ON (B)(6) 2013 BY (B)(6) AT (B)(6) HOSPITAL DUE TO PAIN, DYSPAREUNIA, AND PARTIAL EROSION OF SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76658 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1332541

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention