BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE

    MDR report key: 14789341 · Received June 22, 2022

    Report

    Report Number
    MW5110478
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Report Date
    June 20, 2022
    Manufacturer
    UNK
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOVIE WAS HIDDEN BY DRAPES NOT VISIBLE PATIENT SUFFERED BURNT TO LEFT UPPER ARM. LOT # 769678. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091498 BOVIE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES OJH UNK
    1091499 DRAPE ORTHOPEDIC TRAY OJH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other