BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 10395202 · Received August 12, 2020

    Report

    Report Number
    3010293992-2020-00038
    Event Type
    Death
    Date Received
    August 12, 2020
    Date of Event
    July 20, 2020
    Report Date
    December 27, 2020
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM FRANCE. PROGRAMMING ERROR.

    Description of Event or Problem · 1

    THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM (B)(6). PROGRAMMING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860453 N/A INFISION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death