BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 10173673 · Received June 18, 2020

    Report

    Report Number
    MW5095073
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 16, 2020
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    UDI-DI
    62205000020
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER REPORTED PT WAS IN HOSPITAL ON (B)(6) 2020. HE HAD A FEVER AND PULMONARY EXACERBATION. PT'S MOTHER ALSO REPORTED PT MISSED MORE THAN SIX DOSES DUE TO RESPIRATORY INFECTION. MD: (B)(6); (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636142 RELIZORB CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 3325950000 62205000020

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization