BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDIMOP 20MM VIAL ADAPTER

    MDR report key: 4336973 · Received December 4, 2014

    Report

    Report Number
    3000223297-2014-00001
    Event Type
    Death
    Date Received
    December 4, 2014
    Date of Event
    October 18, 2014
    Report Date
    December 4, 2014
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K963583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDIMOP VIAL ADAPTER DEVICE IS PACKAGED WITH (B)(4)'S DRUG PRODUCT. THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED TO MEDIMOP FOR FURTHER INVESTIGATION AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. 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

    A PHARMACIST REPORTED VIA AN (B)(4) SALES REPRESENTATIVE THAT A (B)(6) YEAR OLD FEMALE PATIENT STARTED ABILIFY MAINTENA (ARIPIPRAZOLE) 400 MG, FREQUENCY UNKNOWN ON AN UNKNOWN DATE FOR SCHIZOPHRENIA. SHE ALSO STARTED CARBAMAZEPINE, UNKNOWN DOSE AND FREQUENCY ON AN UNKNOWN DATE FOR SCHIZOPHRENIA. THE PATIENT HAS NO RELEVANT MEDICAL HISTORY. THE PATIENT'S RELEVANT CONCOMITANT MEDICATIONS AND PAST DRUG HISTORY ARE UNKNOWN. THE PATIENT WAS PRESCRIBED BOTH MEDICATIONS BY A PROVIDER SHE WAS SEEING ON AN OUT-PATIENT BASIS AT A HOSPITAL. ON (B)(6) 2014, SOMETIME AFTER HER THIRD INJECTION, SHE WAS ADMITTED TO A DIFFERENT PSYCHIATRIC HOSPITAL FOR BREAKTHROUGH SYMPTOMS. THE PHARMACIST REALIZED THAT THE PATIENT HAD BEEN TAKING THE ABILIFY MAINTENA AND THE CARBAMAZEPINE TOGETHER AND SHOULD NOT HAVE BEEN. SHE WAS DISCONTINUED FROM THE CARBAMAZEPINE. ON (B)(6) 2014, AT 5 PM, SHE RECEIVED HER 4TH INJECTION OF THE ABILIFY MAINTENA WHILE STILL IN THE PSYCHIATRIC HOSPITAL. AT 5 AM, ON (B)(6) 2014, SHE HAD A PULMONARY EMBOLI AND WAS RUSHED TO A MEDICAL HOSPITAL, AT 7 AM ON (B)(6) 2014, SHE PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782627 MEDIMOP 20MM VIAL ADAPTER VIAL ADAPTER LHI MEDIMOP MEDICAL PROJECTS, LTD. 8072004

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death ABILIFY MAINTENA