BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB IMMOBILIZED LIPASE CARTRIDGE

    MDR report key: 20345558 · Received September 30, 2024

    Report

    Report Number
    MW5160389
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 20, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ALCRESTA THERAPEUTICS INC.
    Product Code
    PLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SMALL PIECE OF THE PLASTIC CONNECTOR FROM THE RELIZORB CARTRIDGE STUCK INTO THE EXTENSION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879254 RELIZORB IMMOBILIZED LIPASE CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS INC. 3400260000

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male Required Intervention