BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBIF SYRINGE

    MDR report key: 2805424 · Received October 19, 2010

    Report

    Report Number
    1220970-2010-00001
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 19, 2010
    Manufacturer
    EMD SERONO, INC.
    Product Code
    FMF
    PMA / PMN Number
    103780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE REPORT WAS RECEIVED FROM A PATIENT IN THE USA AT EMD SERONO ON (B)(4) 2010. THIS (B)(6) FEMALE PATIENT EXPERIENCED THE NEEDLE BREAKING OFF INTO HER STOMACH WHILE INJECTING, THAT REQUIRED SURGICAL INTERVENTION. NO MEDICAL HISTORY WAS REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THIS PATIENT RECEIVED REBIF (INTERFERON-BETA-LA) 44 MCG THREE TIMES PER WEEK BY SUBCUTANEOUS INJECTION FROM (B)(6) 2010. THE DEVICE WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT INJECTED HER REBIF INTO HER STOMACH, AND THE NEEDLE BROKE OFF INTO HER STOMACH. THE PATIENT EXPERIENCED PAIN WHEN MOVING OR COUGHING AFTER THE NEEDLE BROKE OFF IN HER STOMACH. ON (B)(6) 2010, THE PATIENT WAS SCHEDULED TO GO THE HOSPITAL FOR SURGICAL REMOVAL OF THE BROKEN PIECE OF THE NEEDLE. IT WAS NOT KNOWN WHETHER THE PATIENT CONTINUED ADMINISTRATIONS OF REBIF. AT THE TIME OF REPORTING, THE PATIENT HAD NOT RECOVERED FROM THE NEEDLE BREAKING OFF IN HER STOMACH WHILE INJECTING. MULTIPLE (SIX) ATTEMPTS WERE MADE TO CONTACT THE PATIENT AND HER HEALTH CARE PROVIDER IN ORDER TO OBTAIN SPECIFIC PRODUCT INFORMATION, INCLUDING DEVICE RETRIEVAL AND ADDITIONAL INFORMATION ABOUT THE EVENT, INCLUDING OUTCOME OF THE EVENT; HOWEVER, THE ATTEMPTS WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBIF SYRINGE BOROSILICATE TYPE I GLASS BARREL SYRINGE FMF EMD SERONO, INC. F67B01A1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention NOT REPORTED