BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUTERY HIGH TEMP FINE TIP

    MDR report key: 6157513 · Received December 9, 2016

    Report

    Report Number
    3007593903-2016-00012
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 9, 2016
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    HQP
    PMA / PMN Number
    K121441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTER RECEIVED A BOX OF 9 OF 10 CAUTERIES WITH OPEN POUCH. CAUTERIES MODEL AA01 STERILE LOT 0816J LOT # 2016-08-06. THE RETURNED PRODUCT WAS INSPECTED AND IT WAS CONFIRMED THAT THE POUCHED UNITS WERE UNSEALED. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS CATALOG NUMBER AA01 MANUFACTURING LOT NUMBER 2016-08-06, STERILE LOT 0816J. REVIEW OF THE BATCH RECORD SHOWED NO NON-CONFORMANCE NOTED DURING THE POUCHING PROCESS, PACKAGING OR QC INSPECTION PROCESSES. EMPLOYEES WERE MADE AWARE OF THE EVENT AND THE SEALING AND PACKAGING EMPLOYEES WERE INSTRUCTED TO ASSURE ADEQUATE HANDLING AND SEPARATION OF UNSEALED POUCHES.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A BOX WITH 9 OF 10 UNSEALED POUCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813435 CAUTERY HIGH TEMP FINE TIP AA01 HQP BOVIE MEDICAL CORPORATION 0816J

    Patients

    Seq Age Sex Outcome Treatment
    1