BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIZORB CARTRIDGE

    MDR report key: 9391838 · Received November 27, 2019

    Report

    Report Number
    MW5091366
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 21, 2019
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    UDI-DI
    62205000020
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED HE WAS HOSPITALIZED DUE TO ¿ABCESS¿. MD IS AWARE. MD: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181991 RELIZORB CARTRIDGE EMZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 3324600000 62205000020

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization RX MEDS: GABAPENTIN.