BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIXJECT TRANSFER DEVICE

    MDR report key: 2884993 · Received December 19, 2012

    Report

    Report Number
    3000223297-2012-00001
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K963583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIXJECT TRANSFER DEVICE IS PACKAGED IN BAYER'S BETASERON KIT. THERE ARE KNOWN INJECTION SITE REACTIONS FOR BETASERON. THE FOLLOWING IS AN EXCERPT FROM BAYER'S BETASERON PRESCRIBING INFO FOR PHYSICIANS: "INJECTION SITE REACTIONS. IN FOUR CONTROLLED CLINICAL TRIALS, INJECTION SITE REACTIONS OCCURRED IN 78% OF PTS RECEIVING BETASERON WITH INJECTION SITE NECROSIS IN 4%. INJECTION SITE INFLAMMATION (42%), INJECTION SITE PAIN (16%), INJECTION SITE HYPERSENSITIVITY (4%), INJECTION SITE NECROSIS (4%), INJECTION SITE MASS (2%), INJECTION SITE EDEMA (2%) AND NONSPECIFIC REACTIONS WERE SIGNIFICANTLY ASSOCIATED WITH BETASERON TREATMENT (SEE WARNINGS AND PRECAUTIONS). THE INCIDENCE OF INJECTION SITE REACTIONS TRENDED TO DECREASE OVER TIME. APPROXIMATELY 69% OF PATIENTS EXPERIENCED THE EVENT DURING THE FIRST THREE MONTHS OF TREATMENT, COMPARED TO APPROXIMATELY 40% AT THE END OF THE STUDIES." THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED TO MEDIMOP FOR FURTHER INVESTIGATION. MEDIMOP HAS COMPLETED AN INTERNAL INVESTIGATION WHICH FOUND NOTHING TO SUPPORT ANY CORRELATION BETWEEN THE INCIDENT AND THE DEVICE. THERE HAVE BEEN NO OTHER RELATED OR SIMILAR COMPLAINTS ASSOCIATED FOR THE DEVICE LOT IN QUESTION. MEDIMOP WILL SEND A SUPPLEMENTAL MDR IF ANY ADDITIONAL INFO REGARDING THIS EVENT IS OBTAINED.

    Description of Event or Problem · 1

    BAYER HEALTH CARE PHARMACEUTICALS INFORMED MEDIMOP/WEST ON (B)(6) 2012 THAT: (B)(6) WHITE MALE. RELEVANT MEDICAL HISTORY - MULTIPLE SCLEROSIS. LENGTH OF THERAPY: POSSIBLY 15 YEARS WITH BETASERON DRUG KIT. PT CALLED THE BAYER OFFICE FRIDAY, (B)(6) 2012, REPORTING A SWOLLEN INJECTION (SORENESS WITH REDNESS/SWELLING) FROM BETASERON INJECTION GIVEN ON TUESDAY (B)(6) 2012. HE WAS TOLD TO GO TO HIS PRIMARY CARE DOCTOR. THE PT WENT TO THE EMERGENCY ROOM INSTEAD AND WAS CHECKED OUT AND RELEASED WITH DRAINAGE OF SORE, STARTED ON ANTIBIOTICS. SATURDAY (B)(6) 2012 THE PATIENT'S MOTHER REPORTS THAT HE HAD SEVERE HEADACHE AND VOMITING. SHE REPORTED LEAVING THE ROOM FOR A FEW MINUTES AND WHEN SHE CAME BACK HE HAD PASSED AWAY (DIED). THE PT HAD DIED AND HE WAS ON BETASERON BY WHAT APPEARS COULD BE MENINGITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIXJECT TRANSFER DEVICE MIXJECT TRANSFER DEVICE LHI MEDIMOP MEDICAL PROJECTS, LTD. 3809

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death BAYER BETSERON (BATCH (B)(4))