BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN TRIVEX UNIT

    MDR report key: 499700 · Received December 5, 2003

    Report

    Report Number
    1216828-2003-00036
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    November 5, 2001
    Report Date
    December 5, 2003
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE PATIENT HAD RIGHT LEG SURGERY TO REMOVE VARICOSE VEINS USING AN KNOWN TRIVEX DEVICE. TWO DAYS LATER, WHILE CHANGING THE DRESSING, THREE BLOOD BLISTERS WERE FOUND ON THE ANKLE, CALF AND IN THE POPLITEAL SPACE. THE BLISTERS WERE OPENED AND RE-DRESSED. THE PATIENT WAS TOLD BY PHYSICIAN TO WEAR STURDY SHOES AND WALK AROUND IN ORDER TO COUNTERACT SOME SWELLING. HOWEVER, THE PATIENT WORE SLIPPERS BECAUSE THEY COULD NOT GET SHOES ON AND SUBSEQUENTLY EXPERIENCED GREAT PAIN. FIVE DAYS LATER, THE DRESSING WAS REMOVED AND EXAMINATION OF THE PATIENT'S LEG REVEALED THE WOUND AT THE ANKLE HAD ENLARGED TO 5CM X 4CM IN SIZE. THE PATIENT HAD THEIR DRESSING CHANGED ON SEVERAL MORE OCCASIONS USING FIBROLAN AND CUTINOVA CAVITY DRESSING. THE PATIENT REMAINED AN INPATIENT FOR 55 DAYS AND NO IMPROVEMENT HAD OCCURRED. NO OTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRIVEX UNIT * FFS SMITH & NEPHEW, INC. ENDOSCOPY DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O