BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIZORB IMMOBILIZED LIPASE CARTRIDGE

    MDR report key: 19995908 · Received August 14, 2024

    Report

    Report Number
    MW5158473
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Report Date
    August 12, 2024
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMMOBILIZED LIPASE CARTRIDGE (RELIZORB) ENFIT PORTION BREAKS WHEN ATTACHING TO THE TUBE FEEDING. BREAKS EVEN WITH LIGHT TOUCH/PRESSURE. MULTIPLE BROKE IN THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350674 RELIZORB IMMOBILIZED LIPASE CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 00862205000250 3413890000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown