BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1162278 · Received September 5, 2008

    Report

    Report Number
    6000002-2008-08596
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SILICON GEL IN THE DPT WAS PEELED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE MONITOR DRS EDWARDS LIFESCIENCES 500479006 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN