BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACOR

    MDR report key: 2101833 · Received May 18, 2011

    Report

    Report Number
    1219702-2011-00008
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    March 4, 2011
    Report Date
    May 16, 2011
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BELMONT INSTRUMENT CORP IS NOT THE MFR OF THIS DEVICE. IT IS MFG BY SMISSON-CARTLEDGE BIOMEDICAL, LLC. THE HOSP LISTED US ERRONEOUSLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT "SET UP THERMACOR FOR BLOOD TRANSFUSION. BEFORE INITIATED USE, FOUND BLOOD LEAKING FROM THE BOTTOM OF DISPOSABLE. SWITCHED TO BELMONT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACOR WARMER, THERMAL INFUSION PUMP FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other