BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURO CDS

    MDR report key: 18641749 · Received February 2, 2024

    Report

    Report Number
    MW5151047
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    January 25, 2024
    Report Date
    January 31, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUARDED BOVIE TIP, PROTECTIVE SHEATH FELL OFF IN PATIENT. THE SHORT GUARDED BOVIE TIP CAME OUT OF NEURO CDS PACK REFERENCE NUMBER CDS985246K LOT NUMBER 23FMF215. NO HARM TO THE PATIENT AND THE PIECE WAS RETAINED. THE BOVIE WAS REPLACED AND THE CASE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085956 NEURO CDS NEUROLOGICAL TRAY OJG MEDLINE INDUSTRIES, LP - SPT CDS985246K 23FMF215

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention