BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE

    MDR report key: 13062696 · Received December 22, 2021

    Report

    Report Number
    3007208013-2021-00037
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Report Date
    December 22, 2021
    Manufacturer
    BOVIE MEDICAL CORP
    Product Code
    HQP
    UDI-DI
    10607151011014
    PMA / PMN Number
    K121441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER INITIALLY SENT AN EMAIL REQUESTING THAT SOMEONE CONTACT THEM REGARDING "AN ADVERSE EVENT THAT OCCURRED WHILE USING THE BOVIE CAUTERY FINE TIP REF (B)(4)." AFTER REPEATED ATTEMPTS TO FOLLOW UP FOR ADDITIONAL INFORMATION, THE REPORTER RESPONDED ON STATING: "PLEASE DISREGARD. I DO BELIEVE THIS WAS ALL RELATED TO USER ERROR.". ADDITIONAL ATTEMPTS WERE MADE TO GET MORE DETAILS AS TO WHAT OCCURED, BUT WE HAVE RECEIVED NO FURTHER RESPONSE. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT CONTAINS DETAILS REGARDING WHAT HAPPENED, ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT, OR NEED FOR CORRECTIVE ACTIONS A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE REPORTER INITIALLY SENT AN EMAIL REQUESTING THAT SOMEONE CONTACT THEM REGARDING "AN ADVERSE EVENT THAT OCCURRED WHILE USING THE BOVIE CAUTERY FINE TIP REF (B)(4)." NO OTHER DETAILS REGARDING THE EVENT WERE RECEIVED. AFTER REPEATED ATTEMPTS TO FOLLOW UP FOR ADDITIONAL INFORMATION, THE REPORTER RESPONDED ON STATING: "PLEASE DISREGARD. I DO BELIEVE THIS WAS ALL RELATED TO USER ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967657 BOVIE CAUTERY - HIGH TEMP, FINE TIP HQP BOVIE MEDICAL CORP 10607151011014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown