BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIXJECT TRANSFER DEVICE

    MDR report key: 3224679 · Received July 1, 2013

    Report

    Report Number
    3000223297-2013-00001
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 28, 2013
    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 PACKAGING IN BAYER'S BETASERON KIT. THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED TO MEDIMOP FOR FURTHER INVESTIGATION AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO CONFIRM IF THE NEEDLE TIPS REVEALED IN THE PATIENT CT SCAN ARE RELATED TO THE MIXJECT TRANSFER DEVICE. 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 INFORMATION REGARDING THIS EVENT IS OBTAINED.

    Description of Event or Problem · 1

    PER COMPLAINT REPORT TO MEDIMOP: PATIENT: (B)(6), FEMALE. LENGTH OF THERAPY: ABOUT 19 YEARS. (B)(4) NEUROLOGY SALES CONSULTANT REPORTS, THE PATIENT HAS USED THE PRODUCT SINCE 1994. ON AN UNKNOWN DATE, IN (B)(6) 2013, SHE REPORTED AN OPEN INJECTION SITE WOUND TO HER HEALTH CARE PROFESSIONAL (HCP). WHEN SHE WAS SEEN, THE HCP NOTICED OTHER LUMPS ON HER ABDOMEN. ON AN UNKNOWN DATE IN (B)(6) 2013, A CT SCAN REVEALED 10 NEEDLE TIPS THAT BROKE OFF IN HER ABDOMEN, AND SHE DISCONTINUED BETASERON AND WAS PRESCRIBED ANENEX. THE PATIENT HAS ADDITIONAL SCARRING AND BUMPS ON HER LEGS, AND WILL HAVE AN X-RAY SOON. PFDS AND MIXJECT LOT NUMBERS: NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297851 MIXJECT TRANSFER DEVICE MIXJECT TRANSFER DEVICE LHI MEDIMOP MEDICAL PROJECTS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention BAYER BETSERON