BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURO PACK

    MDR report key: 19078681 · Received April 10, 2024

    Report

    Report Number
    1423395-2024-00390
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJG
    UDI-DI
    10195327242282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PLASTIC PIECE FELL OFF THE TIP OF THE PENCIL INTO THE WOUND AND WAS REMOVED WITHOUT INCIDENT BY THE SURGEON. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    TIP FELL OFF INTO WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105317 NEURO PACK OJG MEDLINE INDUSTRIES LP 10195327242282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other