BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 125528 · Received August 23, 1997

    Report

    Report Number
    125528
    Event Type
    Other
    Date Received
    August 23, 1997
    Date of Event
    August 8, 1997
    Report Date
    August 21, 1997
    Manufacturer
    GRAHAM FIELD SURICAL
    Product Code
    FZF
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAKAGE AT SEAM LEVEL OF LEG SPLINT ALLOWING BLOOD TO PENETRATE BETWEEN THE TWO LAYERS OF VINYL. SEWN SEAM ALLOWS LEAKAGE. 8-18-97 AFTERNOON RUN FOR TRAUMA CASE. LEG SPLINT APPLIED TO A VERY BLOODY LEG. SPLINT WAS CLEANED PER PROTOCOL AND HUNG TO DRY. SEVERAL HRS LATER, ON A SECOND AMBULANCE RUN THE SPLINT WAS DRY AND FREE OF VISIBLE CONTAMINATE. THIS SPLINT WAS APPLIED TO PT OF 2ND RUN FOR AN INJURED LEG/ANKLE. NO BLEEDING FROM THIS PT. HOWEVER, UPON ARRIVAL AT THE HOSP, THERE WAS NOTED BLOOD ON THE PTS SHEET AND HIS PANT LEG WAS WET. HE DID HAVE NON WEEPING PIMPLY LIKE AREAS ON HIS LOWER LEG. THEREFORE, THE PT WAS TREATED FOR POSSIBLE BLOOD BORNE CONTAMINATION AND IS TO FOLLOW-UP WITH RETESTING AND HEPATITIS B VACCINATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FRACTURE KIT (LEG SPLINT) FZF GRAHAM FIELD SURICAL HLM37159 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other