BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXXIM MEDICAL

    MDR report key: 195965 · Received November 6, 1998

    Report

    Report Number
    1035160-1998-00006
    Event Type
    Malfunction
    Date Received
    November 6, 1998
    Report Date
    November 5, 1998
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BUTTON ON PENCIL REPORTEDLY STUCK IN THE "ON" POSITION RESULTING IN BURN OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL CUSTOM PROCEDURE PACK LRO MAXXIM MEDICAL 6151891 7052921

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other