BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3092484 · Received May 3, 2013

    Report

    Report Number
    2210968-2013-04940
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, POSTMENOPAUSAL BLEEDING, AND UTERINE POLYPS AND MESH WAS IMPLANTED ON (B)(6) 2003; ALONG WITH THE CONCURRENT PROCEDURES OF HYSTEROSCOPY, DILATION AND CURETTAGE, CYSTOSCOPY, AND VAGINAL TAPE. 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. IT WAS ALSO REPORTED THAT AFTER IMPLANTATION, THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND URINARY/BOWEL PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, POSTMENOPAUSAL BLEEDING, AND UTERINE POLYPS AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURES OF HYSTEROSCOPY, DILATION AND CURETTAGE, CYSTOSCOPY, AND VAGINAL TAPE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND POST MENOPAUSAL BLEEDING AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT AFTER IMPLANTATION, THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND URINARY/BOWEL PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. 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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194454 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1058977

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention