BEUDAMED
    FDA Adverse Event Summary report: N

    COOL COMFORT TEETHER

    MDR report key: 72968 · Received March 3, 1997

    Report

    Report Number
    MW4001786
    Date Received
    March 3, 1997
    Report Date
    January 27, 1997
    Manufacturer
    THE FIRST YEARS, INC.
    Product Code
    KKO
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE IS A STRONG IRRITATING ODOR THAT PERMEATES THIS BRAND OF TEETHERS. FDA-APPROVED PRESERVATIVES ARE ADDED TO THE DISTILLED WATER INSIDE THE TEETHER. A WAITING PERIOD OF 5 DAYS PRIOR TO PACKAGING IS SPECIFIED TO ALLOW ANY "SMELL" TO GO AWAY. CO CONTRACTED MFR POINTS TO SOME RUSH SHIPMENTS OF THIS PRODUCT WHERE THE 5-DAY SPEC MAY HAVE BEEN ELIMINATED AS THE POTENTIAL REASON FOR THE SMELL RPTR ENCOUNTERED. THE 5-DAY WAITING PERIOD HAS NOW BEEN MANDATED, WITHOUT EXCEPTION TO AVOID THIS PROBLEM IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL COMFORT TEETHER FLUID FILLED TEETHING RING KKO THE FIRST YEARS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *