BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXXIM MEDICAL

    MDR report key: 144548 · Received January 14, 1998

    Report

    Report Number
    1035160-1997-00012
    Event Type
    Malfunction
    Date Received
    January 14, 1998
    Report Date
    December 11, 1997
    Manufacturer
    MAXXIM MEDICAL, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FLASH OR ARC FROM ELECTROSURGICAL PENCIL CAUGHT DRAPES ON FIRE DURING SURGICAL PROCEDURE. THERE WAS NO PT OR USER INJURY. THE MFR OF THE ELECTROSURGICAL PENCIL WAS NOTIFIED OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL MINOR OR PACK LRO MAXXIM MEDICAL, INC. 6200395 15

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other