BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH J&J FLOSS WAXED MINT

    MDR report key: 8850593 · Received August 1, 2019

    Report

    Report Number
    8041101-2019-00044
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Report Date
    August 14, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    JES
    UDI-DI
    381370092292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 FEBRUARY 20, 2014. H3, H6: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE, IT WAS CONFIRMED THAT THE METAL CUTTER WAS COMPLETELY SEPARATED FROM THE INSERT ASSEMBLY. IT IS UNKNOWN HOW THE PRODUCT WAS BEING USED AT THE TIME. AT THIS TIME, NO CONCLUSION IS ABLE TO BE DRAWN ABOUT THE CAUSE OF THE METAL CUTTER SEPARATION AS NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE USE OF THE DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP 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. UDI: (B)(4). UPC = (B)(4). EXPIRATION DATE= NA. LOT NUMBER = 0514D. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND IS UNDER EVALUATION/INVESTIGATION AND A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. UPON VISUAL EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE METAL CUTTER WAS COMPLETELY SEPARATED FROM THE CONTAINER. PRODUCT WAS SHIPPED TO MANUFACTURING SITE FOR FURTHER EVALUATIONS. 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

    A FEMALE CONSUMER REPORTED AN EVENT WITH REACH J&J FLOSS WAXED MINT 100YD. THE CONSUMER STATED THAT THE METAL CUTTER CAME OFF DURING USE OF DISPENSING THE FLOSS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647208 REACH J&J FLOSS WAXED MINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER INC 381370092292 0514D 381370092292

    Patients

    Seq Age Sex Outcome Treatment
    1