BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBIJECT II

    MDR report key: 2627223 · Received June 10, 2012

    Report

    Report Number
    MW5025907
    Event Type
    Malfunction
    Date Received
    June 10, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 14, 2012
    Manufacturer
    EMD SERONO
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE REQUIRES PROPER TRAINING. I DID NOT RECEIVE ADEQUATE TRAINING BY MFR. I TRIED TO USE THIS DEVICE ON (B)(6) 2012 AND IT DIDN'T WORK; WHEN I REMOVED PIECES AND TRIED TO REINSTALL SYRINGE, DRUG CAME OUT OF VIAL. I TRIED AGAIN ON (B)(6) 2012 AND DEVICE WORKED BUT CAUSED BAD BLEEDING ON INJECTION SITE. TOLD EMD SERONO ABOUT PROBLEM, BUT I WAS NEVER CONTACTED ABOUT RETURNING PRODUCT. CALLED MS LIFELINES, TOLD THEM ABOUT MULTIPLE PROBLEMS-BUT THEY DO NOT BELIEVE ME. I HAVE MULTIPLE SCLEROSIS. THIS DEVICE IS USED FOR INJECTING A DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBIJECT II AUTO INJECT DEVICE FOR INJECTING SHOTS KZE EMD SERONO REBIJECT II UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other