BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL SYSTEMS

    MDR report key: 237664 · Received August 27, 1999

    Report

    Report Number
    1720159-1999-00079
    Event Type
    Injury
    Date Received
    August 27, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 6, 1999
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ENT PROCEDURE, THE DR HAD A RETRACTOR IN ONE HAND AND A ELECTROSURGICAL PENCIL IN THE OTHER. HE PUT THE PENCIL DOWN AND AT THAT POINT THE BURN WAS NOTICED. THIS WAS A 5MM FULL THICKNESS BURN TO LOWER LEFT LIP ADJACENT TO COMMISURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL SYSTEMS ELECTROSURGICAL UNIT GEI ASPEN LABORATORIES, INC. EXCALIBUR PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other HAND-TROL, LOT #99DHA001.