BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRAWFORD LACRIMAL INTUBATION SET

    MDR report key: 22387 · Received June 12, 1995

    Report

    Report Number
    MW1006206
    Event Type
    Malfunction
    Date Received
    June 12, 1995
    Date of Event
    May 19, 1995
    Report Date
    May 31, 1995
    Manufacturer
    JEDMED INSTRUMENT CO.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PHYSICIAN WAS PLACING THE TUBE INTO PT'S LACRIMAL DUCT, THE TUBE CAME OFF THE PROBE. PROCEDURE ATTEMPTED WITH THREE SEPARATE TUBES. PROCEDURE WAS ABORTED DUE TO MALFUNCTION OF EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRAWFORD LACRIMAL INTUBATION SET LACRIMAL INTUBATION SET HMX JEDMED INSTRUMENT CO. HS-12-1

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Other