BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 11848087 · Received May 18, 2021

    Report

    Report Number
    MW5101420
    Event Type
    Injury
    Date Received
    May 18, 2021
    Report Date
    May 17, 2021
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN THE HOSPITAL FOR A BOWEL OBSTRUCTION FOR 5 DAYS AND HAS BEEN OUT OF MEDICATION FOR A MONTH DUE TO INSURANCE AND PRIOR AUTHORIZATION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737981 RELIZORB CARTRIDGE ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization