BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON/UNIVERSAL PUMPS

    MDR report key: 3030267 · Received March 28, 2013

    Report

    Report Number
    3005619970-2013-00004
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    GETINGE SUZHOU CO. LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    POTENTIAL INCIDENT- PER THE (B)(4) SALES AE: "DR (B)(6) HAS HAD 2 PATIENTS DEVELOP A DVT IN THE PAST MONTH. SHE DOES NOT FEEL OUR PUMPS ARE THE SAME QUALITY AS THEIR PREVIOUS PUMP- COVIDIEN EXPRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128704 FLOWTRON/UNIVERSAL PUMPS JOW GETINGE SUZHOU CO. LTD. 507003

    Patients

    Seq Age Sex Outcome Treatment
    1