BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3053358 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03755
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED ON (B)(6) 2006 DUE TO GENUINE STRESS INCONTINENCE. AFTER IMPLANTATION PATIENT EXPERIENCED PAIN, DYSPAREUNIA, INFECTION AND URINARY/BOWEL PROBLEMS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, VAGINAL PROLAPSE, AND RECTOCELE AND MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODES: 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 SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH 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
    155846 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2952194

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention