BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMSCO OPERATING ROOM LIGHT

    MDR report key: 29704 · Received December 28, 1995

    Report

    Report Number
    29704
    Event Type
    Other
    Date Received
    December 28, 1995
    Date of Event
    December 21, 1995
    Report Date
    December 22, 1995
    Manufacturer
    AMERICAN STERILIZER COMPANY
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THYROIDECTOMY, WHILE WOUND WAS FULLY OPEN, AN UNSTERILE "SWIVEL CAP" FELL OFF SPOTLIGHT #2 DIRECTLY INTO WOUND. CAP REMOVED FROM WOUND. PT TREATED WITH PROPHYLACTIC ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO OPERATING ROOM LIGHT OPERATING ROOM LIGHT FQP AMERICAN STERILIZER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other