BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVID MEDICAL NEURO PACK

    MDR report key: 7776636 · Received August 10, 2018

    Report

    Report Number
    MW5079064
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    July 26, 2018
    Report Date
    August 9, 2018
    Manufacturer
    OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC.
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD 2 NEURO KITS FROM AVID MEDICAL COME WITH BUGS IN THE WRAPPERS. IN ONE A DEAD MOSQUITO WAS IN THE FOAM INSERT LOT NUMBER 1306444, AND IN ANOTHER NEURO PACK LOT NUMBER 1306444 THERE WAS A LIFE FLEA THAT CAME OUT OF THE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614065 AVID MEDICAL NEURO PACK NEURO KIT / NEUROLOGICAL TRAY OJG OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC. 1306444
    614066 AVID MEDICAL NEURO PACK NEURO KIT / NEUROLOGICAL TRAY OJG OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC. 1306444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention