BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIZORB

    MDR report key: 24009476 · Received January 8, 2026

    Report

    Report Number
    MW5181969
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Report Date
    January 3, 2026
    Manufacturer
    ALCRESTA THERAPEUTICS, INC
    Product Code
    PLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RELIZORB CARTRIDGE KEEPS BREAKING. THE COMPANY KEEPS TELLING ME THAT IT IS MY FAULT BUT I AM DOING EVERYTHING CORRECTLY. THE DEVICES ARE VERY EXPENSIVE AND THE COMPANY WILL ONLY REPLACE ONCE INSURANCE APPROVES THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77658 RELIZORB ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown