BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER 250 ML

    MDR report key: 7446283 · Received April 19, 2018

    Report

    Report Number
    MW5076559
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 18, 2018
    Manufacturer
    LEVENTON S. A. U.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RUPTURE OF ELASTOMERIC DRUG RESERVOIR PRIOR TO USE (DOSI-FUSER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286731 DOSI-FUSER 250 ML PUMP, INFUSION FRN LEVENTON S. A. U. 180172L 0329

    Patients

    Seq Age Sex Outcome Treatment
    1 Other