BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUMOBAG

    MDR report key: 360339 · Received November 13, 2001

    Report

    Report Number
    2030595-2001-00001
    Event Type
    Injury
    Date Received
    November 13, 2001
    Date of Event
    October 18, 2000
    Report Date
    November 12, 2001
    Manufacturer
    NUMOTECH, INC.
    Product Code
    KPJ
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AROUND 2:30 PM, OCTOBER 2001, A PT RECEIVING TOPICAL HYPERBARIC OXYGEN THERAPY AT HOME VIA THE NUMOBAG KIT, CALLED NUMOTECH REP ON THEIR CELL PHONE STATING THAT, "I LIT A CIGARETTE BEFORE MY TREATMENT WAS DONE AND I SET THE BAG ON FIRE AND I BURNED MYSELF." NUMOTECH REP ASKED IF PT HAD CALLED 911. PT SAID THEY HAD. NUMOTECH REP STATED THEY WERE ON THEIR WAY TO HELP. PT IS RECOVERING FROM THIRD DEGREE BURNS. NO OTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51233 NUMOBAG NUMOBAG KPJ NUMOTECH, INC. NUMOBAG 104109

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization