BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOJECT 35 CC SYRINGE

    MDR report key: 134675 · Received November 26, 1997

    Report

    Report Number
    1650158-1997-00010
    Event Type
    Other
    Date Received
    November 26, 1997
    Date of Event
    September 1, 1997
    Report Date
    October 27, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION AND NO LOT INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED A GENERAL COMPLAINT. ADVISE WAS PROVIDED TO THE CUSTOMER ON DIFFERENT METHODS OF OPENING THE SYRINGE PACKAGES. CO REVIEWEDTHE COMPLAINT HISTORY FOR THIS PRODUCT AND FOUND NO INCREASING TREND IN THIS TYPE OF REPORT. CO BELIEVES THIS IS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN INCIDENT OF AN INJURY DUE TO THE USE OF MONOJECT SYRINGES. INJURY IS ATTRIBUTED TO OPENING THE RIGID SYRINGE CONTAINERS AND MANIPULATION OF THE SYRINGE PLUNGER DURING MEDICATION ADMINISTRATION. THE INJURY IS DESCRIBED AS REPETITIVE MOTION INJURY TO THE HAND AND WRIST. TREATMENT WAS TIME OFF FROM WORK AND PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT 35 CC SYRINGE SYRINGE FMF SHERWOOD DAVIS AND GECK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention