BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 10733364 · Received October 23, 2020

    Report

    Report Number
    MW5097448
    Event Type
    Injury
    Date Received
    October 23, 2020
    Report Date
    October 22, 2020
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    UDI-DI
    62205000020
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR 14 DAYS FOR A CYSTIC FIBROSIS TUNE UP. DATE OF EVENT ONSET IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195991 RELIZORB CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 3347580000 62205000020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization