BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGEJECT

    MDR report key: 27462 · Received October 25, 1995

    Report

    Report Number
    MW1007442
    Event Type
    Other
    Date Received
    October 25, 1995
    Date of Event
    December 22, 1994
    Report Date
    October 11, 1995
    Manufacturer
    MILTEX INSTRUMENT CO.
    Product Code
    EGM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MILTEX INSTRUMENT CO, INC. 6 OHIO DRIVE, CB 5006, LAKE SUCCESS, NY 11042-0006. WE HAVE CONCLUDED THAT THIS INCIDENT IS NOT A DIRECT RESULT OF THE DEVICE'S FAILURE BUT RATHER IMPROPER USE AND MAINTENANCE AND, AS SUCH, NO REMEDIAL ACTION IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGEJECT DENTAL INTERLIGAMENTARY SYRINGE EGM MILTEX INSTRUMENT CO. 76-50

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other