BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE ULTRACLEAN ACCESS FLOSSER STARTER KIT

    MDR report key: 9602465 · Received January 17, 2020

    Report

    Report Number
    8041101-2020-00002
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Report Date
    February 3, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU
    Product Code
    JES
    UDI-DI
    12547440195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. CORRECTED DATA: UPC; UDI. D10: UPON INVESTIGATION IT WAS NOTED BY MANUFACTURING SITE THAT LOT NUMBER WAS NOT FOR REPLACEMENT HEADS WHICH WAS ORIGINALLY REPORTED IN INITIAL EMDR. AS SUCH, THE DEVICE, LISTERINE ULTRACLEAN ACCESS FLOSSER STARTER KIT , HAS NOT BEEN RETURNED TO THE MANUFACTURER AND SAMPLE RECEIVED UPDATED WAS UPDATED TO "NO". H3: DEVICE NOT EVALUATED BY MANUFACTURING SITE. 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 JUNE 18,2019. 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. UPC: (B)(4), LOT NUMBER:16919D, UDI: (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. THE FLOSSER HEADS WAS RECEIVED OPEN AND USED. AS PER CURRENT PROCEDURE A FIELD SAMPLE EVALUATION IS NOT REQUIRED, SINCE RETURNED FIELD SAMPLE WAS CLASSIFIED AS BIOLOGICAL WASTE AND ARE NOT INSPECTED OR TESTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CONSUMER REPORTED AN EVENT WITH LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT. THE CONSUMER STATED THAT THE WHOLE THING, REPLACEMENT HEAD, SEPARATED FROM THE HANDLE AND STUCK IN CONSUMER MOUTH. THERE WAS NO ADVERSE EVENT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63593 LISTERINE ULTRACLEAN ACCESS FLOSSER STARTER KIT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU 12547440188 16919D 12547440195

    Patients

    Seq Age Sex Outcome Treatment
    1