BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEMP PLUS

    MDR report key: 1898759 · Received October 27, 2010

    Report

    Report Number
    1316463-2010-00009
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 19, 2010
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FLL
    PMA / PMN Number
    K030580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A TELEPHONE INTERVIEW, USER FACILITY RISK MANAGEMENT STAFF INFORMED WELCH ALLYN AS FOLLOWS: THE PT HAS A NEUROLOGIC DIAGNOSIS AND WAS ON A NEURO MEDICAL/SURGICAL UNIT THAT TREATS BRAIN INJURIES. THE INCIDENT WAS DISCOVERED BY RISK MANAGEMENT FOUR DAYS AFTER THE OCCURRENCE. THE THERMOMETER WAS NOT EVALUATED BY FACILITY RISK MANAGEMENT, NOR IS IT ABLE TO BE RETURNED TO WA FOR EVALUATION, BECAUSE IT WAS DISCARDED BY FACILITY STAFF AFTER THE INCIDENT. FACILITY RISK MANAGEMENT STATED THEY BELIEVE THE DEVICE TO BE A WA PRODUCT BECAUSE THERE ARE OTHER (B)(4) PRODUCTS ON THE UNIT. THEREFORE, WE ARE REPORTING THIS IN THE ABUNDANCE OF CAUTION. THE PT HAS BEEN "FINE" SINCE REMOVAL OF THE OBJECTS. METHOD: DEVICE WAS NOT EVALUATED BY WELCH ALLYN SINCE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A USER FACILITY SUBMITTED A MEDWATCH REPORT (B)(4) ALLEGING A (B)(6) MALE PT BIT THROUGH A PROBE COVER AND A THERMOMETER PROBE (BELIEVED BY THE REPORTER TO BE A WELCH ALLYN SURETEMP PLUS) AND INHALED THE COVER AND THE METAL TIP. PT WAS X-RAYED SHOWING THE OBJECTS WERE LODGED IN THE TRACHEA AND THE RIGHT BRONCHUS. THE PT WAS SENT TO THE ICU WHERE THE OBJECTS WERE REMOVED. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURETEMP PLUS FLL WELCH ALLYN, INC. 01692-000

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other