BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTER

    MDR report key: 19213309 · Received April 30, 2024

    Report

    Report Number
    19213309
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    January 25, 2024
    Report Date
    January 26, 2024
    Manufacturer
    WESTMED, INC.
    Product Code
    CAH
    UDI-DI
    00709078000959
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ONE OF THE REINFORCED STAPLE LOADS REINFORCEMENT WAS NOT ATTACHED AND FLOPPING ALL AROUND. IT WOULDN'T SIT WELL WHEN ATTEMPTED TO USE BY NOT LINING UP CORRECTLY ON STAPLE LOAD SO IT WASN'T USED. REMOVED FROM FIELD AND ANOTHER ONE WAS OPENED AND USED INSTEAD. REMOVED FROM FIELD AND GIVEN TO MANAGEMENT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137659 FILTER FILTER, BACTERIAL, BREATHING-CIRCUIT CAH WESTMED, INC. 6221 N3K2598Y 00709078000959

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female