BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 10574024 · Received September 22, 2020

    Report

    Report Number
    MW5096821
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 21, 2020
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    UDI-DI
    62205000020
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED THIS PAST WEEK AND IS CURRENTLY ON A VENTILATOR 24/7 AND HAS TO BE ON OXYGEN. PATIENT ALSO CAME OUT POSITIVE FOR PNEUMONIA. PATIENT MISSED AS WELL DUE TO IT BEING BAD THEY TO THROW IT AWAY.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FOR REPORT # MW5096821 ON 09/23/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035819 RELIZORB CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 100295 62205000020

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization