BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH J&J FLOSS WAXED MINT

    MDR report key: 9069472 · Received September 16, 2019

    Report

    Report Number
    8041101-2019-00050
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Report Date
    September 26, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS INC
    Product Code
    JES
    UDI-DI
    381370092179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON APRIL 8, 2019. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE/DATE OF BIRTH, WEIGHT AND ETHNICITY/RACE WERE NOT PROVIDED FOR REPORTING. THE UDI# IS (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONSUMER REFUSED THE PRODUCT REQUEST. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CONSUMER STATES THAT THE LITTLE METAL PIECE (CUTTER) ON THE CONTAINER OF DENTAL FLOSS BROKE OFF AND TOOK A PIECE OF PLASTIC WITH IT DURING USE. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864643 REACH J&J FLOSS WAXED MINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS INC 381370092179 09819D 381370092179

    Patients

    Seq Age Sex Outcome Treatment
    1