BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENON LIGHT SOURCE

    MDR report key: 528098 · Received June 2, 2004

    Report

    Report Number
    1316463-2004-00005
    Event Type
    Other
    Date Received
    June 2, 2004
    Date of Event
    May 1, 2004
    Report Date
    June 1, 2004
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    GCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN FOR A LAPAROSCOPIC CHOLECYSTECTOMY, MASTECTOMY AND TRAM FLAP. DURING THE TRAM (TRANSVERSE RECTUS ABDOMINAL MUSCLE) FLAP, THE PHYSICIAN NOTED A BURN ON THE PT'S RIGHT BREAST. LIGHTED REFRACTOR AND LIGHT SOURCE REMOVED FROM THE SURGICAL PROCEDURE AND SENT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENON LIGHT SOURCE LIGHT SOURCE GCT WELCH ALLYN, INC. 49801-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other