BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 446818 · Received March 7, 2003

    Report

    Report Number
    2242056-2003-00003
    Event Type
    Injury
    Date Received
    March 7, 2003
    Date of Event
    February 27, 2003
    Report Date
    March 3, 2003
    Manufacturer
    ALTO DEVELOPMENT CORP./DBA ACE MEDICAL CORP.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A SPARK/FLAME FROM THE CAUTERY PENCIL DURING T & A SURGERY CAUSING A SUPERFICIAL BURN TO THE NASOPHARYNGEAL AREA OF THE PT. THE SURGERY WAS COMPLETED WITHOUT INCIDENT. RECOVERY WAS WITHOUT INCIDENT AND THE PT WAS DISCHARGED THE SAME DAY OF SURGERY WITH NO RESIDUAL EFFEFCTS APPARENT OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ELECTROSURGICAL SUCTION COAGULATOR GEI ALTO DEVELOPMENT CORP./DBA ACE MEDICAL CORP. NA 024

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other| R