BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GONOGON 50 DETERMINATING

    MDR report key: 27094 · Received October 10, 1995

    Report

    Report Number
    MW4000899
    Event Type
    Injury
    Date Received
    October 10, 1995
    Report Date
    March 24, 1995
    Manufacturer
    BBL
    Product Code
    JSX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TEST KIT WAS OPENED ON 6/27/95. THERE WAS NO REAGENT IN THE STAFF CONTROL BOTTLE WHICH IS USED TO DETERMINE FALSE POSITIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GONOGON 50 DETERMINATING GONOGON 50 DETERMINATING JSX BBL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R