BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH MINT WAXED DENTAL FLOSS

    MDR report key: 10829119 · Received November 10, 2020

    Report

    Report Number
    MW5097788
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 7, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER, INC.
    Product Code
    JES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A 5-PACK OF REACH DENTAL FLOSS THAT IS OBVIOUSLY DEFECTIVE AS IT SEPARATES DURING USE AND LEAVES RESIDUAL COTTON FIBERS STUCK BETWEEN TEETH AND GUMS. THIS RELATES TO LOT # 08020D. I BELIEVE THE DEFECTIVE PRODUCT CAN RESULT IN BOTH INFLAMMATION AND INFECTION WHEN USED. I HAVE REACHED OUT TO THE MANUFACTURING AND REPORTED THE DEFECTIVE PRODUCT; THEY HAVE ACKNOWLEDGED MY COMPLAINT BY MAILING A NUMBER OF COUPONS THAT WOULD ALLOW ME TO BUY MORE OF THEIR DEFECTIVE PRODUCTS WITH A (B)(6) DISCOUNT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279657 REACH MINT WAXED DENTAL FLOSS FLOSS, DENTAL JES JOHNSON & JOHNSON CONSUMER, INC. UPC 8137109108 08020D

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR