BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOSTAR

    MDR report key: 1900983 · Received November 12, 2010

    Report

    Report Number
    MW5018191
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SANOFI-AVENTIS
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE WERE SHIPPED A NUMBER OF BOXES OF LANTUS SOLOSTAR PENS MFG BY SANOFI-AVENTIS, (B)(4), EACH CONTAINING 5 PENS FROM (B)(6) MAIL SERVICE, (B)(6) LOCATED IN (B)(6). ONE OF THE PENS IS DEFECTIVE. WHEN I CONTACTED (B)(6) MAIL SERVICE, THEY STATED, THEY CAN'T DO ANYTHING UNTIL THEY HEAR FROM THE MFR. WHEN I CONTACTED THE MFR, THEY SAID THEY CAN'T DO ANYTHING UNTIL THEY GET AN INVOICE FROM (B)(6) SHOWING WHAT I PAID. THEY ALL INSIST ON GETTING PAID FIRST BUT WHEN THERE IS A PROBLEM, THE CONSUMER IS SUBJECTED TO BUREAUCRATIC NEVER-ENDING FOOT-DRAGGING. THIS IS WHY I AM COMPLAINING. THEY DON'T HAVE TO CHASE ME FOR PAYMENT, AND I SHOULD NOT HAVE TO CHASE THEM FOR A REPLACEMENT PRODUCT OR REFUND! DOSE OR AMOUNT: 25 UNITS DAILY. DATES OF USE: (B)(6) 2010, DIAGNOSIS OR REASON FOR USE: TYPE 2 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOSTAR LANTUS SOLOSTAR NSC SANOFI-AVENTIS 0F 114A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR