BEUDAMED
    FDA Adverse Event Summary report: N

    CVS ALL IN ONE HANDLE FLOSSER

    MDR report key: 2854791 · Received November 23, 2012

    Report

    Report Number
    MW5027754
    Date Received
    November 23, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CVS
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN USING A "ALL-IN-ONE HANDLED FLOSSER" FOR THE FIRST TIME, THE FLOSSER BROKE, CAUSING A PIECE OF PLASTIC TO SNAP OFF AND HIT ME IN THE EYE. THE FLOSSER HAS EXCHANGEABLE/DISPOSABLE FLOSSING HEADS THAT INSERT INTO THE HANDLE. THE FLOSSER COMES PRE-LOADED WITH ONE OF THE FLOSSING HEADS ALREADY INSTALLED. I USED THE FLOSSER FOR THE FIRST TIME, DIRECTLY OUT OF THE PACKAGE, WITH THE PRE-LOADED HEAD. AFTER USING THE FLOSSER, WHEN ATTEMPTING TO REMOVED THE DISPOSABLE HEAD TO THROW IT AWAY, A PIECE OF PLASTIC ON THE HOLDER (SPECIFICALLY, THE BRIDGE OF PLASTIC AT THE TOP OF THE HANDLE WHICH HOLDS THE HEADS IN PLACE) SNAPPED OFF, FLEW, AND HIT ME IN THE EYE, CAUSING A CORNEAL ABRASION. I DON'T BELIEVE THERE WAS ANY USER ERROR INVOLVED AS I WAS USING THE PRODUCE FOR THE FIRST TIME, WITH THE DISPOSABLE FLOSSING HEAD THAT WAS INSTALLED BY THE MANUFACTURER. EITHER THE PIECE THAT HOLDS THE HEADS IN PLACE IS TOO THIN, OR THERE WAS SOME SORT OF DEFECT IN THE ONE I PURCHASED. PERSONAL CARE. GROOMING. PURCHASE DATE: (B)(6) 2012. THIS DATE IS AN ESTIMATE. I SAVED THE PRODUCT, BROKEN PIECE AND THE PACKAGING, AND CONTACTED THE MANUFACTURER BY TELEPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVS ALL IN ONE HANDLE FLOSSER TOOTH FLOSSER WITH HANDLE AND DETACHABLE DISPOSABLE FLOSSING HEADS JES CVS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR