BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYROTEST 30ML DILUTION VIAL

    MDR report key: 3283759 · Received August 8, 2013

    Report

    Report Number
    MW5031384
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    August 2, 2013
    Report Date
    August 7, 2013
    Manufacturer
    QI MEDICAL INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PYROTEST VIAL CONTAINED BROWN CONTAMINATE, POSSIBLY DRIED GLUE, BUT WE ARE UNABLE TO DETERMINE IF THE CONTAMINATE WAS INSIDE OR OUTSIDE THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375984 PYROTEST 30ML DILUTION VIAL PYROTEST 30ML DILUTION VIAL LHI QI MEDICAL INC. 12713K

    Patients

    Seq Age Sex Outcome Treatment
    1