BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULIZER (DIRECT PATIENT INTERFACE)

    MDR report key: 10178757 · Received June 19, 2020

    Report

    Report Number
    MW5095096
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 9, 2020
    Manufacturer
    PERRIGO/CATALENT PHARMA SOLUTIONS, LLC
    Product Code
    CAF
    UDI-DI
    45802008801
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PLASTIC PART OF INHALER IS NOT ALLOWING A SPRAY TO COME OUT. PATIENT TOOK THE CANISTER AND PUT IT IN A PLASTIC SLEEVE FROM A COMPETITOR AND THE INHALER WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637233 NEBULIZER (DIRECT PATIENT INTERFACE) NEBULIZER (DIRECT PATIENT INTERFACE) CAF PERRIGO/CATALENT PHARMA SOLUTIONS, LLC 19MC092 45802008801

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR