BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 207859 · Received January 15, 1999

    Report

    Report Number
    207859
    Event Type
    Other
    Date Received
    January 15, 1999
    Date of Event
    November 16, 1998
    Report Date
    December 7, 1998
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN OPERATING ROOM FOR APPLICATION OF ARCH BARS AND (INTERNAL MAXILLARY FIXATION), RESECT ANKYLOTIC LEFT TEMPOROMANDIBULAR JOINT, RECONSTRUCT ASCENDING RAMUS MANDIBLE AND TEMPORO-MANDIBULAR JOINT WITH RIB BONE CARTILAGE CONSTRUCT. DURING RIB GRAFT HARVEST, PT SUSTAINED BURN TO CHEST WHEN THE ELECTROCAUSTERY PENCIL WAS INADVERTENTLY LEANED UPON. WOUND MANAGED BY EXCISION AND ELLIPTICAL CLOSURE WITH REABSORBABLE SUTURES AND STERI-STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA HANDSWITCHING PENCIL GEI VALLEYLAB, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other