BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE BLADE ELECTRODE 6" (15.24CM)

    MDR report key: 7528061 · Received May 18, 2018

    Report

    Report Number
    3007593903-2018-00025
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 17, 2018
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    10607151010079
    PMA / PMN Number
    K093025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT WAS ORIGINALLY REPORTED ON (B)(6) 2018. INITIAL CONVERSATION ADDRESSING PATIENT INJURY WAS FOUND TO BE (B)(6) 2018. ADDITIONAL INFORMATION WAS REQUIRED TO CLARIFY THAT THERE WAS A PATIENT INJURY ON (B)(6) 2018 AND CONFERENCE CALL WAS HELD AND THE INFORMATION WAS CONFIRMED. MDR REPORT WAS ISSUED UPON CONFIRMATION OF THE INJURY. INVESTIGATION WAS COMPLETED AND THE COMPLAINT CAN'T BE CONFIRM FOR PRODUCT MALFUNCTION SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SAMPLES FROM THE SAME LOT 0315C WERE TESTED AND FOUND WITHIN SPECIFICATIONS. IN ADDITION, A DHR REVIEW WAS COMPLETED AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED, SINCE IS NOT CONFIRMED THAT THE DEVICE CONTRIBUTED TO THE ALLEGED REPORTED COMPLAINT OF A PATIENT BURN DURING A PROCEDURE AFTER USING BOVIE'S ELECTRODE (B)(4). CURRENTLY, BOVIE MEDICAL CORPORATION HAVE AN OPEN CAPA (B)(4) TO ADDRESS THE LATE REPORTING MDRS. DURING THE INITIAL INVESTIGATION IT WAS FOUND THAT 3 COMPLAINTS INVESTIGATIONS (INCLUDING THIS INVESTIGATION) WERE INITIALLY DOCUMENTED WITHOUT HAVING THE SUFFICIENT INFORMATION PREVENTING THE MEDICAL REPORTING DETERMINATION TO BE ACCURATE.

    Description of Event or Problem · 1

    REPORTED COMPLAINT ALLEGE THAT A PATIENT RECEIVED A SKIN BURN DURING AN INCREASE MASTOPEXY PROCEDURE USING A BOVIE'S ELECTRODE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368661 BOVIE BLADE ELECTRODE 6" (15.24CM) ES0014EU GEI BOVIE MEDICAL CORPORATION ES0014EU 0315C 10607151010079

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability