BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2055362 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00340
    Event Type
    Death
    Date Received
    March 28, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/25/2011. (B)(4) - NECROTIZING FASCIITIS. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO 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 A PT UNDERWENT A SLING PROCEDURE ON (B)(6) 2011. THE INTRA OPERATIVE COURSE AND TIME IN SHORT STAY WAS UNCOMPLICATED. THE PT DEVELOPED ACUTE GROIN PAIN AND PRESENTED TO THE EMERGENCY ROOM. THE PT WAS TRANSFERRED AND HAD RAPIDLY PROGRESSIVE NECROTIZING FASCIITIS REQUIRING MASSIVE MUSCLE DEBRIDEMENT AND REMOVAL OF THE TAPE. LAB TESTS WERE DONE AND THE PT HAD A STREP A ORGANISM PRESENT IN HER BODY WHICH CAUSED THE BILATERAL INFECTION. IT WAS REPORTED THAT INSTEAD OF HER IMMUNE SYSTEM FIGHTING THE INFECTION, IT WORKED AGAINST HER. THE PT DIED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3489757

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death