BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENCINE LIGHT SOURCE

    MDR report key: 370648 · Received December 26, 2001

    Report

    Report Number
    370648
    Event Type
    Other
    Date Received
    December 26, 2001
    Date of Event
    December 18, 2001
    Report Date
    December 20, 2001
    Manufacturer
    GENSINE BIOSURGERY
    Product Code
    FCW
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING SURGICAL PROCEDURE. METAL CONNECTOR OF LIGHT SOURCE BURNED PT'S RIGHT BREAST. AREA OF BURN APPROX SIZE OF QUARTER AND SKIN WHITISH IN COLOR. TOO SOON TO TELL DEPTH OF BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58579 GENCINE LIGHT SOURCE FIBEROPTIC LIGHT SOURCE FCW GENSINE BIOSURGERY 89-8700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other