BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONATEMP ESOPHAGEAL STETHOSCOPE SERIES 400

    MDR report key: 275074 · Received April 21, 2000

    Report

    Report Number
    1317749-2000-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2000
    Date of Event
    March 23, 2000
    Report Date
    April 21, 2000
    Manufacturer
    KENDAL HEALTHCARE
    Product Code
    BZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    QA MANAGEMENT OF MEDICAL CENTER REPORTS TO SALES REP OF MANUFACTURER THAT A PATIENT WAS USING AN ESOPHAGEAL STETHOSCOPE MANUFACTURED BY THE MFR. UPON REMOVAL OF PRODUCT, CUSTOMER ALLEGES THE END CAP OF PRODUCT HAD DISLODGED FROM THE MAIN ESOPHAGEAL STETHOSCOPE. TWENTY-FOUR HOURS LATER, THE PATIENT VOMITED UP THE END PIECE OF THE STETHOSCOPE. AS A RESULT, THE PATIENT REMAINED IN HOSPITAL FOR OBSERVATION AND A FULL SERIES OF X-RAYS. NO PATIENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONATEMP ESOPHAGEAL STETHOSCOPE SERIES 400 ESOPHAGEAL STETHOSCOPE BZW KENDAL HEALTHCARE * 104955

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other