BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTH PRO

    MDR report key: 7661135 · Received July 3, 2018

    Report

    Report Number
    3005798905-2018-00655
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    July 3, 2018
    Manufacturer
    MHC MEDICAL PRODCUTS, LLC.
    Product Code
    NBW
    PMA / PMN Number
    K113192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOT READING STRIPS NTO FUNCTIONING AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501630 HEALTH PRO GLUCSOE MONITORING SYSTEM NBW MHC MEDICAL PRODCUTS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1