BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL ESOPHAGEAL STETHESCOPE

    MDR report key: 266245 · Received February 25, 2000

    Report

    Report Number
    1046367-2000-00011
    Event Type
    Malfunction
    Date Received
    February 25, 2000
    Date of Event
    January 12, 2000
    Report Date
    February 21, 2000
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    BZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ESOPHAGEAL STETHESCOPE WAS REMOVED FROM PT. THE PT WAS STILL INTUBATED AND UPON SUCTIONING, IT WAS NOTICED THAT THE BLUE PLASTIC TIP WAS LEFT IN THE BACK OF THE PT'S THROAT. DR WAS ABLE TO REMOVE TIP FROM PT'S THROAT. THE PT WAS NOT INJURED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL ESOPHAGEAL STETHESCOPE ESOPHAGEAL STETHESCOPE BZT DEROYAL INDUSTRIES, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other