BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGENIEUX

    MDR report key: 69682 · Received February 12, 1997

    Report

    Report Number
    2027060-1997-09003
    Event Type
    Other
    Date Received
    February 12, 1997
    Date of Event
    December 19, 1996
    Report Date
    February 12, 1997
    Manufacturer
    ALM HOSP EQUIPMENT
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FINISH PAINT ON A LIGHT ARM FLAKED AND POSSIBLY FELL INTO THE OPEN WOUND OF A PT. THE HOSP INFORMED MFR TECH THAT THE PT SUFFERED NO INFECTION FROM THE PAINT. UPON INVESTIGATION, THE TECH FOUND A LOCATION THAT HAD CHIPPED PAINT. THE CHIPPED FORK WAS REPLACED BY A NEW ONE. AFTER INSPECTION BY MFR'S QUALITY CONTROL, IT WAS DETERMINED THAT THE CHIPPING WAS CAUSED BY THE IMPACT OF TWO LIGHTHEADS HIT TOGETHER BY HOSP PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGENIEUX SURGICAL LIGHTING FQP ALM HOSP EQUIPMENT 310013 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other