BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXXIM MEDICAL - HENLEY MEDICAL

    MDR report key: 290304 · Received August 1, 2000

    Report

    Report Number
    290304
    Event Type
    Injury
    Date Received
    August 1, 2000
    Date of Event
    June 7, 2000
    Report Date
    June 15, 2000
    Manufacturer
    HENLEY INTERNATIONAL
    Product Code
    LBG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    6/6/2000 PT REC'D FLUIDOTHERAPY TREATMENT WITH A BIER BLOCK IN PLACE. AFTER TREATMENT THE TOURNIQUET WAS RELEASED, SENSATION RETURNED AND PT COMPLAINED OF SEVERE BURNING PAIN IN FINGERS OF LEFT HAND. FINGERS NOTED TO BE DUSKY IN COLOR. PT RELEASED WHEN SYMPTOMS SUBSIDED WITH TREATMENT OF MEDICATION AND COOL WATER. PT RETURNED LATER THAT NIGHT WITH COMPLAINTS OF PAIN AND BY NEXT MORNING HAD LARGE BLISTERS ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL - HENLEY MEDICAL FLUIDOTHERAPY LBG HENLEY INTERNATIONAL 110D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization