BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILLIPS

    MDR report key: 1000346 · Received February 15, 2008

    Report

    Report Number
    MW5005563
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 14, 2008
    Manufacturer
    PHILLIPS
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS SUSTAINING LINEAR SUPERFICIAL ABRASIONS ON BILATERAL ARMS THAT SHE CLAIMS WERE CAUSED BY NEW BLOOD PRESSURE CUFF. TO BE USED ON PATIENT MONITORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS BP PATIENT MONITOR TUBING DXN PHILLIPS
    2 PHILLIPS BP MONITOR MODULE DXN PHILLIPS
    3 PHILLIPS ANTIMICROBIAL COATED CUFF-ADULT EXTRA LONG DXQ PHILLIPS 40539

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR