BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2772268 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-05785
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT URINARY STRESS INCONTINENCE ON AN UNKNOWN DATE AND A SLING WAS IMPLANTED. TWO AND A HALF YEARS LATER, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION CONFIRMED BY CULTURE, WHICH GREW OUT E. COLI. 90% OF THE SYMPTOMS RESOLVED BUT SHE WAS LEFT WITH A TENDER AREA IN THE RIGHT VAGINAL FORNIX. THE PATIENT STATES THAT SHE CAN FEEL THE MESH AND WANTS IT REMOVED. THE DOCTOR PLANED TO REMOVE A SMALL AREA OF MESH UNDER LOCAL WITH SEDATION BUT IT WAS DISCOVERED DURING THE PROCEDURE THAT THE MESH IS NOT VISIBLE OR ERODED. THE PATIENT HAS ALSO RECENTLY DEVELOPED A PARKINSON'S LIKE NEUROLOGICAL DISEASE WITH ELEMENTS OF PARALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention