BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3033197 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03385
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL/REVISION ON (B)(6) 2011 DUE TO EXPOSED MESH AT THE VAGINAL APEX. NO ADDITIONAL INFORMATION WAS PROVIDED.(B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 06/16/2016 ADDITIONAL INFORMATION: AGE/DATE OF BIRTH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2003 CONCURRENTLY WITH ABDOMINAL SACROCOLPOPEXY (MERSILENE MESH), CYSTOSCOPY, AND BILATERAL SALPINGO-OOPHORECTOMY DUE TO VAGINAL VAULT PROLAPSE, STRESS URINARY INCONTINENCE, FECAL INCONTINENCE, AND URETHRAL HYPERMOBILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND A SLING WAS IMPLANTED. 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
    136693 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1084358

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention