BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2760505 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05646
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 7, 2012
    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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTERECTOMY AND RECTAL PERINEAL REVISION DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED INFLAMED CHRONIC PAINFUL AREAS, DYSPAREUNIA, BAND TOO TIGHT, VAGINAL PAIN, VAGINAL BLEEDING, URINARY PROBLEMS, INCONTINENCE, ABDOMINAL PELVIC PAIN, AND VOIDING ISSUES - BLADDER CONTROL. THE PATIENT WAS TREATED FOR PROLAPSE FROM (B)(6) 2007 AND THEN UNDERWENT MESH REVISION ON (B)(6) 2007. THE PATIENT EXPERIENCED VAGINAL MESH EROSION AND HAD MESH REVISION ON (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF VAGINAL MESH EROSION ON (B)(6) 2013.

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-05642 AND 2210968-2012-05643. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND (B)(6) 2007 AND MESH WAS USED. IT WAS NOT STATED WHICH PRODUCT WAS IMPLANTED DURING WHICH SURGERY. IT WAS REPORTED THAT SHE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1215144

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention