BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 447696 · Received March 11, 2003

    Report

    Report Number
    2242056-2003-00004
    Event Type
    Injury
    Date Received
    March 11, 2003
    Date of Event
    February 27, 2003
    Report Date
    March 10, 2003
    Manufacturer
    ALTO DEVELOPMENT CORP. / DBA A&E 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

    DURING POST-OPERATIVE CARE, BURNS TO PATIENT'S LIP AND PALATE WERE DISCOVERED. NO UNUSUAL OCCURRENCES DURING THE ADENOIDECTOMY WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other