BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACH CLEANSEPASTE TARTAR CONTROL FLOSS

    MDR report key: 1133197 · Received August 21, 2008

    Report

    Report Number
    8041101-2008-00010
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 16, 2008
    Report Date
    August 21, 2008
    Manufacturer
    JOHNSON & JOHNSON HEALTHCARE PRODUCTS
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    APPEARANCE OF SAMPLE RECEIVED MET STANDARD.

    Description of Event or Problem · 1

    NON REPORTABLE EVENT RECEIVED APRIL 17, 2008. CONSUMER STATED... USED DENTAL FLOSS IN MOUTH AND PART OF HER TOOTH CAME OUT. DENTIST WAS NOT CONTACTED. MEDICAL BILL RECEIVED JULY 22, 2008. JULY 31, REVIEW DETERMINED AS SERIOUS INJURY REQUIRING DENTAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REACH CLEANSEPASTE TARTAR CONTROL FLOSS DENTAL FLOSS JES JOHNSON & JOHNSON HEALTHCARE PRODUCTS 1096D

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other