BEUDAMED
    FDA Adverse Event Other Summary report: N

    CODMAN & SHURTLEFT, INC.

    MDR report key: 250362 · Received November 17, 1999

    Report

    Report Number
    250362
    Event Type
    Other
    Date Received
    November 17, 1999
    Date of Event
    October 13, 1999
    Report Date
    October 21, 1999
    Manufacturer
    CODMAN & SHURTLEFT, INC. PRODUCT COMPLAINT DEPT.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING TONSILLECTOMY, A BURN TO THE MOUTH OCCURRED. IT IS SUSPECTED THAT THE BIPOLAR FORCEPS CONTACTED THE SIDE OF THE MOUTH AND CAUSED THIS BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN & SHURTLEFT, INC. MALIS BIPOLAR COAGULATOR & FORCEPS GEI CODMAN & SHURTLEFT, INC. PRODUCT COMPLAINT DEPT. CMC-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other FOREPS 80-2961, LOT # 9909N.