BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL SHERIDAN

    MDR report key: 271247 · Received March 28, 2000

    Report

    Report Number
    271247
    Event Type
    Malfunction
    Date Received
    March 28, 2000
    Date of Event
    March 23, 2000
    Report Date
    March 27, 2000
    Manufacturer
    THE KENDALL COMPANY LP
    Product Code
    BZW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS S/P LEFT UPPER LUNG RESECTION, DONE ON 03/22/2000. AN ESOPHAGEAL STETHOSCOPE SIZE 18 FRENCH WAS INSERTED PRIOR TO SURGERY AND REMOVAL AFTER SURGERY. THIS DEVICE IS AN ANESTHESIA PRODUCT FOR TEMPERATURE MONITORING. THE NEXT DAY 03/23/2000, PT VOMITTED WHILE DRINKING SOUP AND BROUGHT UP A LATEX CAP. THIS CAP APPARENTLY CAME OFF (SEPARATED) FROM CATHETER PROBE. THE CAP IS 2 INCHES LONG AND APPEARS TO BE GLUED ON. THE PT SHOWED NO SIGNIFICANT OR OBSERVED COMPLICATIONS FROM THIS PRODUCT PROBLEM. THE MFR, KENDALL, WAS CONTACTED AND A REP CAME ON 03/24/2000 TO EVALUATE AND FILL A COMPLAINT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL SHERIDAN ESOPHAGEAL STETHOSCOPE - SONATEMP BZW THE KENDALL COMPANY LP SONATEMP SERIES 700 104955

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other