BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 110610 · Received August 1, 1997

    Report

    Report Number
    1933255-1997-00008
    Event Type
    Malfunction
    Date Received
    August 1, 1997
    Date of Event
    May 9, 1997
    Report Date
    July 31, 1997
    Manufacturer
    POND'S (INDIA) LIMITED FAICHNEY MEDICAL CO
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CO WAS INFORMED OF THE EVENT BY THE SALES REPRESENTATIVE OF THE DISTRIBUTOR FROM WHOM THE HOSPITAL PURCHASED THE THERMOMETER. A PHYSICIAN AT THE HOSPITAL ALLEGED THAT THE THERMOMETER EXCEEDED TEMPERATURE OF HIS PATIENT. THE THERMOMETER IN QUESTION APPEARED TO 2 TO 3 F HIGH. WANTED CO TO KNOW ABOUT THE PROBLEM. CO REQUESTED THAT HE RETURN THE THERMOMETER ON 07/08/97 AND REVERTED FOR TESTING THE SAME DAY. RESULTS WERE RECEIVED ON 07/22/97, WHICH SHOWED THAT THE THERMOMETER DID READ THREE DEGREES HIGH. TO THIS DATE, NO SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE GLASS MERCURY THERMOMETER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER RECTAL CLINICAL THERMOMETER FLL POND'S (INDIA) LIMITED FAICHNEY MEDICAL CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN