BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEMP II

    MDR report key: 491618 · Received October 22, 2003

    Report

    Report Number
    1644019-2003-00029
    Event Type
    Injury
    Date Received
    October 22, 2003
    Date of Event
    September 12, 2003
    Report Date
    September 23, 2003
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A SKIN TAG REMOVED FROM RIGHT EYELID/TEMPORAL REGION. THE STERILE FIELD DRAPE IGNITED WHEN HAND HELD CAUTERY UNIT WAS ACTIVATED. SURGEON REMOVED DRAPE AS QUICKLY AS POSIBLE AND APPLIED A COLD COMPRESS TO THE SITE. PT HAS BEEN SEEN IN OP DEPARTMENT AGAIN IN 2003, AND THE WOUND HAS BEEN REDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEMP II CAUTERY HQP ALCON - HOUSTON OPTEMP II UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention