BEUDAMED
    FDA Adverse Event Death Summary report: N

    20MM VIAL ADAPTER

    MDR report key: 3528008 · Received December 17, 2013

    Report

    Report Number
    3000223297-2013-00002
    Event Type
    Death
    Date Received
    December 17, 2013
    Report Date
    December 13, 2013
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DISTRIBUTES THE 20MM VIAL ADAPTER TO (B)(4) PHARMACEUTICAL FOR DISTRIBUTION WITH THEIR ABILIFY MAINTENA DRUG PRODUCT. UPON ADD'L F/U WITH (B)(4) PHARMACEUTICAL THEY HAD NO REASON TO BELIEVE THAT THE (B)(4) VIAL ADAPTER WAS RELATED TO THE ADVERSE EVENT OR HAD ANY STERILITY ISSUES AS STATED IN THE INITIAL COMPLAINT. RATHER, THEY WERE ONLY REQUESTING INFO FROM (B)(4) AS PART OF THEIR INVESTIGATION TO RULE OUT THAT THE VIAL ADAPTER STERILITY COULD HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT.

    Description of Event or Problem · 1

    MEDIMOP RECEIVED AN INITIAL REPORT FROM (B)(6) PHARMACEUTICAL THAT THEY HAD RECEIVED A LACK OF EFFECT COMPLAINT WHERE THERE MAY BE A POTENTIAL STERILITY ISSUE. ADD'L INFO RECEIVED FROM (B)(6) PHARMACEUTICAL STATED THE ADVERSE EVENT WAS ON A PT THAT IS ASSOCIATED WITH THE LACK OF EFFECT HAD A DEATH ASSOCIATED WITH IT. AN INITIAL CONVERSATION WITH THE MEDICAL DOCTOR INDICATED THAT THE PT SHOWED A LOT OF IMPROVEMENT WITH THE ABILIFY MAINTENA. THE PT HAD OTHER COMORBID CONDITIONS. THE MEDICAL DOCTOR HAS ALSO COMMUNICATED THAT HE DOES NOT BELIEVE THAT THE DEATH IS RELATED TO ABILIFY MAINTENA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658322 20MM VIAL ADAPTER VIAL ADAPTER LHI MEDIMOP MEDICAL PROJECTS, LTD. 3918, 3919 OR 3920

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ABILIFY MAINTENA - (B)(4) PHARMACEUTICALS