BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBIF SYRINGE

    MDR report key: 3185537 · Received June 19, 2013

    Report

    Report Number
    1220970-2013-00001
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    May 1, 2008
    Report Date
    June 19, 2013
    Manufacturer
    EMD SERONO, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PT AND HIS HEALTH CARE PROVIDER TO OBTAIN ADDITIONAL INFO; HOWEVER, THE ATTEMPTS WERE NOT SUCCESSFUL. THEREFORE, AN EVAL ON THE DEVICE COULD NOT BE PERFORMED AT THIS TIME. AN ADDITIONAL COMMUNICATION WAS SENT OUT TO THE PT. IF ANY FURTHER INFO IS RECEIVED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS CASE REPORT FROM A PHARMACY IN THE USA WAS RECEIVED AT EMD SERONO ON (B)(6) 2013. THIS (B)(6) MALE PT'S NEEDLE BROKE OFF INTO THE THIGH, WHICH WAS ASSESSED AS MEDICALLY SIGNIFICANT BY THE COMPANY, WHILE BEING TREATED WITH REBIF. NO MEDICAL HISTORY WAS REPORTED. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMIN CAPSULE AND IBUPROFEN CAPSULE 200MG. THE PT RECEIVED REBIF (INTERFERON BETA-1A) 44 MCG THREE TIMES PER WEEK BY SUBCUTANEOUS INJECTION FROM AN UNK DATE TO ONGOING. IN 2008, THE PT'S REBIF NEEDLE TIP BROKE OFF INTO HIS THIGH AND HE SUBSEQUENTLY REQUIRED SURGERY TO REMOVE THE TIP OF THE NEEDLE. THE PT ALSO DEVELOPED AN INFECTION. ACTION TAKEN WITH REBIF WAS NOT REPORTED. AT THE TIME OF REPORTING, THE OUTCOMES OF NEEDLE BROKE OFF IN THIGH AND INFECTION WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278537 REBIF SYRINGE BOROSILICATE TYPE I GLASS BARREL SYRINGE FMF EMD SERONO, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention