BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2143347 · Received June 29, 2011

    Report

    Report Number
    2210968-2011-00838
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MESH EXPOSURE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2002 FOR INCONTINENCE. THE PATIENT EXPERIENCED VAGINAL BLEEDING IN (B)(6) 2010. IN (B)(6) 2010, THE PHYSICIAN FOUND THAT THE MESH HAD ERODED INTO THE VAGINA UNDER THE URETHRA. ON (B)(6) 2011, 2.5CM OF SLING WAS REMOVED AND THEN THE PATIENT DEVELOPED AN INFECTION. THE REMAINDER OF THE SLING REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON NA 949363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention