BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-TEMP CAUTERY

    MDR report key: 2673045 · Received July 25, 2012

    Report

    Report Number
    1211998-2012-00003
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 23, 2012
    Manufacturer
    BEAVER VISITEC INTERNATIONAL, INC.
    Product Code
    HAM
    PMA / PMN Number
    K833648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RETURNED, BUT IT APPEARS TO BE A BVI MANUFACTURED UNIT. THIS IS NOT CONSISTENT WITH THE LOT NUMBER REPORTED. THIS PRODUCT LINE WAS RECENTLY ACQUIRED BY MEDTRONIC AND IS NOW MANUFACTURED AT BEAVER VISITEC INTERNATIONAL. HOWEVER, THE REPORTED LOT NUMBER OF THIS PRODUCT SIGNIFIES THAT IT WAS MANUFACTURED BY MEDTRONIC PRIOR TO THIS ACQUISITION. INVESTIGATION IS IN PROGRESS, WHICH INCLUDES INFORMATION FROM MEDTRONIC REGARDING DATE OF MFR, EXPIRATION DATE, AND COMPLAINT TRENDING. EXPECT A FOLLOW-UP REPORT TO BE PROVIDED ON OR ABOUT (B)(4) 2012.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER REPORTED VERBATIM, "DURING SURGERY, A SWAB CAUGHT FIRE AND BURNED THE SURGEON'S THUMB AND THE SIDE OF THE NOSE AND CHEEK OF THE PATIENT." REPEATED ATTEMPTS TO REACH DR. (B)(6) WERE MADE SINCE (B)(6). HE RETURNED OUR CALL ON (B)(6) 2012. OUR CONVERSATION FOUND THAT SURGERY WAS CONDUCTED TO REMOVE A TUMOR ON THE EYE LID. THE SURGEON DECIDED TO DO A CAUTERIZATION OF A SMALL ARTERY NEXT TO THE LACRIMAL GLAND AND CLOSE TO THE CORNEA. TO PROVIDE EASIER ACCESS HE USED A GAUZE (100% COTTON, NON-WOVEN) PLACING IT UNDER HIS LEFT THUMB TO HELP MAKE THE AREA WHERE THE CAUTERIZATION EASIER TO REACH. AS CAUTERIZATION STARTED, HE FELT A SHARP PAIN IN HIS LEFT THUMB AND STARTED SMELLING SOMETHING BURNING. ALMOST IMMEDIATELY THE PATIENT COMPLAINED INDICATING A SHARP PAIN ON THE SIDE OF HER NOSE. DR. (B)(6) IMMEDIATELY STOPPED AND AS HE REMOVED HIS THUMB AWAY FROM THE PATIENT, HE NOTICED THAT THE GAUZE UNDER HIS THUMB HAD DISINTEGRATED LEAVING A RED MARK ON HIS THUMB AND ON THE PATIENT'S NOSE. THE NEXT DAY THE RED MARK ON DR. (B)(6)'S THUMB WAS GONE. HOWEVER, THE PATIENT WAS STILL SHOWING A RED MARK AND CREAM USED TO TREAT SURFACE BURNS WAS APPLIED. THE PATIENT TODAY DOES NOT SHOW ANY MARK. DR. (B)(6) HAS NOT ISSUES WITH HIS THUMB AND HAS BEEN ABLE TO PERFORM SURGERIES WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-TEMP CAUTERY ACCU-TEMP CAUTERY 1/2 SHAFT W/FINE TIP HAM BEAVER VISITEC INTERNATIONAL, INC. NA 71674800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention