BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP

    MDR report key: 1559772 · Received December 11, 2009

    Report

    Report Number
    1045254-2009-00053
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    November 11, 2009
    Report Date
    November 13, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HQP
    PMA / PMN Number
    K833648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFO. THIS PRODUCT WAS BEING USED FOR TREATMENT. THE PT'S WEIGHT WAS NOT OBTAINED BY THE FACILITY, STATED THE PT WAS SMALL FRAMED. ADDITIONAL FOLLOW UP MEDICAL TREATMENT PERFORMED INCLUDED: LATISSE, HYPERBARIC OXYGEN TREATMENT SESSIONS, EYELASH EXTENSIONS, AND A SCLERA INJECTION AT THE SITE OF A SCAB (INNER RIM MARGIN OF UPPER EYELID). THE PT IS CURRENTLY RECOVERING WITH REDNESS AND DISCOMFORT WHILE BLINKING. THE TOPICAL SOLUTION LATISSE ADVERTISED SAFETY INFO STATED "THE MOST COMMON SIDE EFFECTS AFTER USING LATISSE SOLUTION ARE AN ITCHING SENSATION IN THE EYES AND / OR EYE REDNESS." A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS IS THE FIRST REPORT FOR THIS PRODUCT LOT AND ONLY TWO OTHER EVENTS OF A SIMILAR NATURE (I.E. SINGED EYELASH/EYEBROW) HAS BEEN REPORTED FOR THIS PRODUCT LINE LOOKING BACK AT COMPLAINT RECORDS FOR THE LAST 5 YEARS. NO ANOMALIES WERE FOUND IN THE ELECTRONIC MFG DOCUMENT. EXAMINATION OF THE TIP UNDER A MICROSCOPIC SHOWED THE PRODUCT FUNCTIONED AS INTENDED WITH NO VISIBLE ANOMALIES. ELECTRICAL TESTS PER SPECIFICATIONS SHOWED RESISTANCE MEASURED 0.5 OHMS AND VOLTAGE MEASURED 1.9 VOLTS FOR 2 SECONDS WHICH IS IN CONFORMANCE WITH THE PRODUCT SPECIFICATIONS. INSTRUCTION FOR USE INCLUDES BUT IS NOT LIMITED TO; "FIRE WARNING: HEAT GENERATED BY THE TIP CAN IGNITE FLAMMABLE MATERIALS. DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS SUCH AS FACIAL HAIR, PREPARATION AGENTS, ALCOHOL VAPORS, DRAPES, OR GOWNS. PROPER SURGICAL TECHNIQUE, SUCH AS THE APPLICATION OF WATER-BASED LUBRICANT TO FACIAL HAIR NEAR THE SURGICAL SITE OF ELECTROCAUTERY USE, MUST BE FOLLOWED TO PREVENT POTENTIAL PT INJURY."

    Description of Event or Problem · 1

    DR WAS PERFORMING A BLEPHAROPLASTY ON THE RIGHT AND LEFT EYELIDS. THE PT WAS PLACED UNDER IM SECTION WITH STERILE PREP (BETADINE) AND DRAPE. WHILE PERFORMING THE SURGERY ON THE LEFT HE WAS CAUTERIZING THE MEDIAL FAT PAD "AT LEAST ONE INCH AWAY" IN THE CREASE OF THE EYELID WHEN THE MEDIAL 2/3 OF UPPER AND LOWER EYELASHES SINGED/BURNED. WET GAUZE WAS PLACED ON THE FIELD EARLIER, BUT NOT OVER LASHES AT TIME OF BURN. THE PT'S EYES WERE CLOSED AND THE PT'S VISION WAS NOT INVOLVED/DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP 86 HQP HQP MEDTRONIC XOMED, INC. 8442000 60504100

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention