BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIXJECT TRANSFER DEVICE

    MDR report key: 2236960 · Received September 1, 2011

    Report

    Report Number
    3000223297-2011-00001
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 25, 2011
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K963583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 A EXCERPT FROM BAYER'S BETASERON PRESCRIBING INFORMATION 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 TENDED TO DECREASE OVER TIME. APPROXIMATELY 69% OF PTS 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 PERFORMED AN INTERNAL INVESTIGATION WHICH FOUND NOTHING TO SUPPORT THE STATEMENT MADE IN THE COMPLAINT. IN ADDITION, THERE HAVE BEEN NO OTHER RELATED OR SIMILAR COMPLAINTS FOR THE DEVICE LOT IN QUESTION. MEDIMOP WILL SEND A SUPPLEMENTAL MDR IF ANY ADDITIONAL INFORMATION REGARDING THIS EVENT IS OBTAINED.

    Description of Event or Problem · 1

    WEST PHARMACEUTICAL SERVICES (WEST) / MEDIMOP WAS DIRECTLY CONTACTED BY PT WITH THE FOLLOWING COMPLAINT. COMPLAINED OF A LEG INFECTION, STATING IS WAS FROM A NON-STERILE NEEDLE THAT "YOU DON'T SEE UNTIL AFTER YOU'VE USED IT" (QUOTED BY THE PT). THE PT DID NOT PROVIDE A DESCRIPTION OF THE PROBLEM NEEDLE. PT ALSO REPORTED THAT HIS PHYSICIAN PLACED HIM ON AMOXICILLIN DUE TO CELLULITIS ON RIGHT LEG AT INJECTION SITE. PT SAID HE WAS USING THE MEDIMOP DEVICE WHICH WAS DISTRIBUTED WITHIN BAYER'S BETASERON DRUG KIT. WEST CONTACTED PT FOR ADDITIONAL INFORMATION CONCERNING COMPLAINT. PT REFUSED TO ELABORATE AND STATED THAT HE DID NOT WANT TO DISCUSS THE ISSUE ANY FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIXJECT TRANSFER DEVICE MIXJECT TRANSFER DEVICE LHI MEDIMOP MEDICAL PROJECTS, LTD. 2827

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BAYER BETASERON (B)(4)