BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELI ON -WALMART

    MDR report key: 2438090 · Received January 30, 2012

    Report

    Report Number
    MW5024096
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    WALMART
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RELI ON INSULIN U-100 PRODUCT -81131-0311-68- SYRINGE WILL NOT WORK CORRECTLY, PT HAS TO USE EXTENSIVE FORCE ON PISTON/PLUNGER TO RECEIVE INSULIN. PLUNGER STICKS AFTER PT DRAWS INSULIN INTO SYRINGE AND INJECTS NEEDLE INTO INJECTION SITE, THEN PT CAN NOT PUSH PLUNGER WITHOUT USING EXTREME FORCE, VERY SCARY AND DANGEROUS. LOOKS LIKE PLASTIC IS DEFECTIVE. THIS HAS HAPPENED 10 TO 20 TIMES IN THE PAST 4 MONTHS. OTHERS HAVING SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELI ON -WALMART U-100 SYRINGE FMF WALMART 1193213

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR