BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIZORB

    MDR report key: 20722797 · Received November 19, 2024

    Report

    Report Number
    20722797
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING SET UP ON THE ELIZORB IMMOBILIZED LIPASE CARTRIDGE FILTER, THE FILTER CRACKED WHEN IT WAS ATTACHED TO THE FEEDING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56185 RELIZORB ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 100300/100301 3413890000

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male