BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER

    MDR report key: 97941 · Received June 12, 1997

    Report

    Report Number
    1933255-1997-00007
    Event Type
    Injury
    Date Received
    June 12, 1997
    Date of Event
    May 26, 1997
    Report Date
    June 11, 1997
    Manufacturer
    POND'S (INDIA) LIMITED, INITIAL IMPORTER/DISTRIBUTOR: FAICHNEY MED CO.
    Product Code
    FLK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER ALLEGES THAT THE BULB OF THE THERMOMETER BROKE OFF IN HIS INFANT DAUGHTER'S RECTUM AFTER TAKING A RECTAL TEMPERATURE. THE INFANT WAS TAKEN TO HOSP WHERE BOWEL MOVEMENTS WERE INDUCED, WHICH SUCCESSFULLY CLEARED THE THERMOMETER TIP FROM THE RECTUM. THE INFANT WAS DISCHARGED WITHIN 3-4 HRS WITH NO FURTHER TREATMENT, AND HAS SINCE BEEN SEEN BY A DR AND NO FURTHER PROBLEMS OR TREATMENT WAS NECESSARY. THIS REPORT IS SUBMITTED BY FAICHNEY MEDICAL CO ("FAICHNEY") BASED ON INFO RECEIVED BY FAICHNEY, WHICH FAICHNEY MAY OR MAY NOT HAVE HAD AN OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO SUBMISSION OF THIS REPORT. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY FAICHNEY (A) THAT THE PRODUCT DESCRIBED HEREIN WAS MFG, IMPORTED, OR DISTRIBUTED BY FAICHNEY; (B) THAT ANY CAUSAL RELATIONSHIP EXISTS BETWEEN SUCH PRODUCT AND ANY ACTUAL OR POTENTIAL INJURY; OR (C) THAT ANY REPORTABLE EVENT HAS IN FACT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER THERMOMETER FLK POND'S (INDIA) LIMITED, INITIAL IMPORTER/DISTRIBUTOR: FAICHNEY MED CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention