BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSPACER

    MDR report key: 16919707 · Received May 11, 2023

    Report

    Report Number
    MW5117490
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 9, 2023
    Manufacturer
    RESPIRATORY DELIVERY SYSTEMS, INC
    Product Code
    BYP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS PRESCRIBED A MICROSPACER FOR USE WITH AN INHALER. THE MICROSPACER SPLIT AND BECAME UNUSABLE AFTER 3 USES WITH THE INHALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042471 MICROSPACER MOUTHPIECE, BREATHING BYP RESPIRATORY DELIVERY SYSTEMS, INC 47360-0172-01 0007

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female