BEUDAMED
    FDA Adverse Event Summary report: N

    1047429-2015-00003

    MDR report key: 5153019 · Received October 15, 2015

    Report

    Report Number
    1047429-2015-00003
    Date Received
    October 15, 2015
    Date of Event
    September 16, 2015
    Report Date
    October 14, 2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL INC. IS THE MANUFACTURER OF A CUSTOM CONVENIENCE KIT THAT CONTAINS A CAUTERY MANUFACTURED BY DYNAMIC DIAGNOSTICS INC. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 FROM (B)(6) STATING THE "TEFLON TIP OF THE ELECTROSURGERY PENCIL WAS NOT COATED TO THE SHAFT. DURING ACTIVATION OF THE PENCIL A SPARK/SPARKS WERE SEEN COMING FROM THE UNCOATED SPACE TO THE PATIENT RESULTING IN A BURN. THE PATIENT WAS TREATED FOR THE BURN." ON SEPTEMBER 17, 2015 AVID ISSUED A COMPLAINT TO THE MANUFACTURER OF THE COMPLAINED CAUTERY DYNAMICS DIAGNOSTICS INC. FOR THEIR CAUTERY BTN SWITCH TEFLON CTD WITH HOLSTER PART # PEN21NS LOT # 150411 AND GAVE THEM (B)(6) CONTACT INFORMATION SO THAT THEY COULD RETRIEVE THE COMPLAINED CAUTERY DIRECTLY FROM (B)(6). DYNAMICS DIAGNOSTICS INC. ISSUED COMPLAINT (B)(4). NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other