BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABCO BATTERY OPERATED CAUTERIES

    MDR report key: 883221 · Received July 16, 2007

    Report

    Report Number
    MW5003084
    Event Type
    Injury
    Date Received
    July 16, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 16, 2007
    Manufacturer
    ABCO DEALERS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    A CHILD CAME IN FOR A SUBUNGUAL HEMATOMA. I USE THE ABCO BATTERY OPERATED CAUTERY FOR THIS. I CHECKED TO SEE THAT THE CAUTERY TIP WAS PATENT AND TESTED IT FOR HEATING. IT HEATED UP AS USUAL. I THEN CLEANED THE AREA WITH AN ALCOHOL WIPE, LET IT DRY AND THEN PRECEDED TO OPERATE THE CAUTERY. IT HEATED UP AS IT'S SUPPOSED TOO. I THEN PLACED IT TO THE NAIL OF THE CHILD'S RIGHT MIDDLE FINGER. IT BURNED THROUGH THE NAIL WITH OUT ANY DIFFICULTY. HOWEVER, WHEN I REMOVED THE TIP, THE END OF THE CAUTERY WAS MISSING. THE CHILD DID NOT FEEL ME RELIEVE THE PRESSURE FROM THE SUBUNGUAL HEMATOMA, NOR DID SHE FEEL ANY METAL OR PAIN. I THEN OBTAINED A X-RAY TO LOOK FOR ANY FOREIGN BODY FROM THE TIP OF THE CAUTERY. THE X-RAY SHOWED THE TIP PRESENT IN THE NAIL. I THEN ENLIGHTENED THE FATHER OF THE SITUATION. WE HAD A SIMILAR INCIDENT APPROXIMATELY 1 MONTH AGO, INVOLVING THE SAME OUTCOME. WE HAVE USED THIS TECHNIQUE FOR OVER 10 YEARS WITHOUT SUCH A PROBLEM. DOSE: APPLY TO AFFECTED AREA. FREQUENCY: ONE TIME. ROUTE: TOP. DATES OF USE: 2007. DIAGNOSIS: SUBUNGUAL HEMATOMA. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABCO BATTERY OPERATED CAUTERIES FINE TIP HIGH TEMPERATURE CAUTERY GEI ABCO DEALERS, INC. UNK 0306-2
    2 ABCO BATTERY OPERATED CAUTERIES FINE TIP HIGH TEMPERATURE CAUTERY GEI ABCO DEALERS, INC. UNK 10

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR