BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERICARDIAL SUMP

    MDR report key: 505254 · Received December 18, 2003

    Report

    Report Number
    2028837-2003-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2003
    Report Date
    December 16, 2003
    Manufacturer
    CALIFORNIA MEDICAL LABORATORIES, INC.
    Product Code
    DTS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERICARDIAL SUMP CARDIAC SUMP. DTS CALIFORNIA MEDICAL LABORATORIES, INC. NA S03493

    Patients

    Seq Age Sex Outcome Treatment
    1 *