BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIZORB

    MDR report key: 21265158 · Received January 29, 2025

    Report

    Report Number
    MW5165409
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 23, 2025
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FEMALE CONNECTOR OF RELIZORB CARTRIDGE REPORTED TO BE DAMAGED ON MULTIPLE OCCASIONS AND LEAKING FOR THIS PATIENT SPECIFICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843025 RELIZORB ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 3420440000

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male