BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFA-LAB EMERGENCY DENTURE REPAIR KIT

    MDR report key: 271640 · Received March 31, 2000

    Report

    Report Number
    MW1018536
    Event Type
    Malfunction
    Date Received
    March 31, 2000
    Date of Event
    March 31, 2000
    Report Date
    March 31, 2000
    Manufacturer
    INFA-LAB, INC.
    Product Code
    EBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    POWDER AND LIQUID CONTAINED IN PRODUCT ARE COMPLETELY UNLABELED EXCEPT FOR WARNING OF FLAMMABILITY. THE INSTRUCTIONS INDICATE THAT THE COMPONENTS ARE TO BE MIXED. RPTR IS CONCERNED REGARDING POTENTIAL FOR NUMEROUS PROBLEMS RELATED TO LACK OF LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFA-LAB EMERGENCY DENTURE REPAIR KIT EMERGENCY DENTURE REPAIR KIT EBO INFA-LAB, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA