BEUDAMED
    FDA Adverse Event Summary report: N

    RELIZORB

    MDR report key: 8174928 · Received December 17, 2018

    Report

    Report Number
    MW5082198
    Date Received
    December 17, 2018
    Report Date
    December 14, 2018
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLINICAL ESCALATION REVIEWED FOR RELIZORB. PER DELIVERY SCHEDULING ASSESSMENT ON (B)(6) 2018 PATIENTS GRANDFATHER STATED THAT THE PATIENT MISSED MORE THAN 15 DOSES OF THE MEDICATION. CALLED AND SPOKE TO PATIENTS HIPAA VERIFIED GRANDFATHER (B)(6) WHO STATED THAT THE PATIENT MISSED THE DOSES OF MEDICATION BECAUSE SHE WAS IN THE HOSPITAL FOR 3 WEEKS BECAUSE HER OXYGEN LEVELS WERE LOW AND SHE HAD A LUNG INFECTION. HE STATED THAT HER PHYSICIANS ARE AWARE OF HER ADMISSION. ALL QUESTIONS AND CONCERNS ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007508 RELIZORB ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1