BEUDAMED
    FDA Adverse Event Other Summary report: N

    49801 LIGHT SOURCE

    MDR report key: 527719 · Received May 11, 2004

    Report

    Report Number
    527719
    Event Type
    Other
    Date Received
    May 11, 2004
    Date of Event
    May 1, 2004
    Report Date
    May 1, 2004
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    GCT
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other