BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBIF SYRINGE

    MDR report key: 3221426 · Received July 2, 2013

    Report

    Report Number
    1220970-2013-00002
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    September 17, 2010
    Report Date
    July 2, 2013
    Manufacturer
    EMD SERONO, INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE (SIX) ATTEMPTS WERE MADE TO CONTACT THE PT AND HER HEALTH CARE PROVIDER IN ORDER TO OBTAIN SPECIFIC PRODUCT INFO INCLUDING DEVICE RETRIEVAL AND ADD'L INFO ABOUT THE EVENT INCLUDING OUTCOME OF THE EVENT; HOWEVER, THE ATTEMPTS WERE NOT SUCCESSFUL. IF ADD'L INFO IS REC'D IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THIS CASE REPORT WAS REC'D FROM A PT IN THE USA AT EMD SERONO ON (B)(6) 2010. THIS (B)(6) FEMALE PT EXPERIENCED THE NEEDLES BREAKING OFF IN HER SKIN WHILE INJECTING THAT REQUIRED SURGICAL INTERVENTION. NO MEDICAL HISTORY WAS REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THIS PT REC'D REBIF (INTERFERON-BETA-LA) 44 MCG THREE TIMES PER WEEK BY SUBCUTANEOUS INJECTION FROM (B)(6) 2010, TO ONGOING AT THE TIME OF THE EVENT. ON (B)(6) 2010, THE PT INJECTED HER REBIF INTO HER STOMACH, AND THE NEEDLE BROKE OFF IN HER STOMACH. ON (B)(6) 2010, THE PT WAS SCHEDULED TO GO THE HOSPITAL FOR SURGICAL REMOVAL OF THE BROKEN PIECE OF THE NEEDLE. ON (B)(6) 2013, THE PT REPORTED SHE HAD A TOTAL OF THREE NEEDLES BREAK OFF IN HER SKIN OVER ONE YR AGO. THE PT STATED TWO WERE IN HER BELLY AND ONE WAS IN HER RIGHT ARM AND SHE STILL HAD ONE NEEDLE IN HER BELLY AREA. THE PT REPORTED HER PHYSICIAN TOLD HER IT WOULD NOT HURT HER AND THE NEEDLE HAD MOVED TOO DEEP TO BE REMOVED. THE PT REPORTED SHE HAD BEEN OFF OF REBIF FOR APPROX ONE YR (PRESUMABLY DISCONTINUED IN 2012) AND RESTARTED AT THE 44MCG DOSE IN (B)(6) 2013 USING REBIJECT II. AT THE TIME OF THE EVENT THE PT INJECTED REBIF BY MANUAL INJECTION AND REBIJECT II. HOWEVER, IT WAS NOT REPORTED WHICH METHOD LED TO THE NEEDLE BREAKING OFF INTO THE SKIN. AT THE TIME OF REPORTING, THE PT HAD NOT RECOVERED FROM THE NEEDLES BREAKING OFF IN THE SKIN AS ONE NEEDLE REMAINED IN HER BELLY AREA. ADD'L INFO WAS REC'D FROM THE PT ON (B)(6) 2013 INCLUDED: REBIF THERAPY DATA, ADVERSE EVENT DETAILS AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300421 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