BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRISOL ACID CONCENTRATE

    MDR report key: 20304267 · Received September 25, 2024

    Report

    Report Number
    2150060-2024-00046
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 25, 2024
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FKQ
    UDI-DI
    00677964091766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STERIS IS NOT THE MANUFACTURER OF THE CENTRISOL ACID CONCENTRATE SUBJECT OF THE REPORTED EVENT. STERIS HAS NOTIFIED THE MANUFACTURER, ROCKWELL MEDICAL, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY. STERIS IS SUBMITTING THIS REPORT SOLELY IN RESPONSE TO THE RECEIVED MEDWATCH. NO ADDITIONAL ISSUES NOTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5157962 THAT THEIR SB-352 AND SB-353 JUGS OF CENTRISOL ACID CONCENTRATE HAD THE SAME COLOR AND STYLE LABELS. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199054 CENTRISOL ACID CONCENTRATE CENTRISOL ACID CONCENTRATE FKQ MEDIVATORS INC. SB-353 00677964091766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown