BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIXJECT TRANSFER DEVICE

    MDR report key: 2885055 · Received December 19, 2012

    Report

    Report Number
    3000223297-2012-00002
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    October 19, 2012
    Report Date
    December 11, 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 (B)(4) OF PTS RECEIVING BETASERON WITH INJECTION SITE NECROSIS IN (B)(4). INJECTION SITE INFLAMMATION ((B)(4)), INJECTION SITE PAIN ((B)(4)), INJECTION SITE HYPERSENSITIVITY ((B)(4)), INJECTION SITE NECROSIS ((B)(4)), INJECTION SITE MASS ((B)(4)), INJECTION SITE EDEMA ((B)(4)) AND NONSPECIFIC REACTIONS WERE SIGNIFICANTLY ASSOCIATED WITH BETASERON TREATMENT (SEE WARNINGS AND PRECAUTIONS). THE INCIDENCE OF INJECTION SITE REACTIONS TENDED TO DECREASE OVER TIME. APPROXIMATELY (B)(4) OF PTS EXPERIENCED THE EVENT DURING THE FIRST THREE MONTHS OF TREATMENT, COMPARED TO APPROXIMATELY (B)(4) 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

    PT: (B)(6) MALE. LENGTH OF THERAPY: ABOUT 15 YRS. PT EXPERIENCING SAME SYMPTOMS AS PT IN (B)(4) AND IS HOSPITALIZED AND DIAGNOSED WITH MENINGITIS. REPORT WAS COLLECTED AS A RESULT OF PHONE F/U WITH PT'S PHYSICIAN. ON (B)(6) 2012, 6:52PM: RECEIVED VOICEMAIL FROM THE PHYSICIAN, WHO REPORTED THE LOT # BA7973A. INDICATION - MULTIPLE SCLEROSIS. WAS MENINGITIS DIAGNOSIS CONFIRMED - YES, IT WAS DEFINITELY VIRAL MENINGITIS. MEDICAL HISTORY - MULTIPLE SCLEROSIS AND SEVERE DEPRESSION. CONCOMITANT CONDITIONS - DEPRESSION. CONCOMITANT MEDICATIONS - PROZAC, REMERON AND ENAPLEX. THE REPORTED EVENT - STARTED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIXJECT TRANSFER DEVICE MIXJECT TRANSFER DEVICE LHI MEDIMOP MEDICAL PROJECTS, LTD. 3554 OR 3555

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization BAYER BETSERON (BATCH BA7973A)