BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORO SET HKL, CHEMNITZ

    MDR report key: 590308 · Received April 7, 2005

    Report

    Report Number
    1526863-2005-00018
    Event Type
    Malfunction
    Date Received
    April 7, 2005
    Report Date
    March 8, 2005
    Manufacturer
    MEDEX
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE ROTATOR SEPARATED FROM THE MANIFOLD. THE MANIFOLD WAS REPLACED WITH NO FURTHER ISSUES. NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORO SET HKL, CHEMNITZ FLUID ADMINISTRATION SET FPA MEDEX NA 35A24K29RV08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN