BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1811980 · Received August 18, 2010

    Report

    Report Number
    2210968-2010-00935
    Event Type
    Injury
    Date Received
    August 18, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2010. DURING THE PROCEDURE THERE WAS AN ARTERIAL BLEED WHICH MADE IT DIFFICULT TO CLEARLY SEE THE OPERATIVE FIELD. THIS RESULTED IN PART OF THE PLASTIC SHEATH BEING RETAINED IN THE PATIENT. THE PATIENT WAS SEEN SEVERAL TIMES IN THE EMERGENCY ROOM FOR PAIN FOLLOWING THE SURGERY, BUT PHYSICIANS WERE UNABLE TO DETERMINE WHAT WAS CAUSING THE PROBLEM BECAUSE THE PLASTIC SHEATH IS NOT RADIOPAQUE. THE PATIENT LATER DEVELOPED AN ABSCESS IN THE LOCATION WHERE THE SHEATH WAS LEFT IN AND THEN HAD ANOTHER SURGERY ON (B)(6) 2010 TO REPAIR THE ABSCESS. THE SURGEON OPINES THAT THE ABSCESS WAS RELATED TO THE RETAINED SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3386971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention