BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 9335114 · Received November 15, 2019

    Report

    Report Number
    MW5091135
    Event Type
    Injury
    Date Received
    November 15, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ALCRESTA THERAPEUTICS INC.
    Product Code
    PLQ
    UDI-DI
    62205000020
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019 PT (B)(6) STATES SHE WAS HOSPITALIZED 2 WEEKS AGO FOR RESPIRATORY ISSUES. EVENT ONGOING. UNK USE 1 CARTRIDGE IN-LINE WITH ENTERAL FEEDING TUBE SET AS DIRECTED. CHANGE CARTRIDGE EVERY 500ML OF ENTERAL FORMULA. (MAXIMUM OF 2 CARTRIDGES USED DAILY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120398 RELIZORB CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS INC. 62205000020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization