BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2953837 · Received February 10, 2013

    Report

    Report Number
    2210968-2013-00920
    Event Type
    Injury
    Date Received
    February 10, 2013
    Report Date
    January 20, 2013
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT TOTAL VAGINAL HYSTERECTOMY DUE TO STRESS URINARY INCONTINENCE. FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, RECURRENCE, BLEEDING, AND DYSPAREUNIA. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2011 DUE TO MESH EROSION FROM SLING PROCEDURE AND VAGINAL BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED. (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 AND MESH WAS IMPLANTED CONCURRENTLY WITH AN ANTERIOR/POSTERIOR VAGINAL REPAIR DUE TO ABNORMAL PAP SMEAR AND MENOMETRORRHAGIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    57867 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 1250974

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention