BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUL-GLO

    MDR report key: 130832 · Received October 30, 1997

    Report

    Report Number
    MW4002038
    Event Type
    Malfunction
    Date Received
    October 30, 1997
    Date of Event
    October 27, 1997
    Report Date
    October 30, 1997
    Manufacturer
    BARNES-HIND, INC.
    Product Code
    KYC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM WAS OBSERVED ON 10/27/97 OR 10/28/97. WHEN USED, THE STRIPS BURN/STING THE PT'S EYE, ARE STIFF AND SCRATCH THE EYE, AND DO NOT DYE THE EYE WELL. THE STRIPS HAVE TO BE APPLIED MORE THAN ONCE. CONCERN FOR PT SAFETY, MISSED DIAGNOSIS AND POTENTIAL FOR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUL-GLO FLUOROSCEIN STRIPS KYC BARNES-HIND, INC. NA B ZE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN