BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFLO INCENTIVE DEEP BREATHING EXCERCISOR

    MDR report key: 1586566 · Received January 11, 2010

    Report

    Report Number
    3003898360-2010-00023
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 9, 2009
    Report Date
    December 21, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION BUT THE INVESTIGATION IS NOT COMPLETED YET. A F/U INVESTIGATION WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CUSTOMER REPORTED A BROKEN PIECE OF PLASTIC FOUND IN THE CENTRAL HOUSING OF THE DEVICE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFLO INCENTIVE DEEP BREATHING EXCERCISOR INCENTIVE BREATHING EXERCISOR BWF TELEFLEX MEDICAL NA 01C900254

    Patients

    Seq Age Sex Outcome Treatment
    1