BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 9156768 · Received October 3, 2019

    Report

    Report Number
    MW5090229
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    UDI-DI
    62205000020
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT MOTHER STATED THAT THE PT WAS IN THE HOSP FOR PANCREATITIS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947619 RELIZORB CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 3310720000 62205000020

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization