BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH LIST DENTOTAPE 20M FROM 3 14

    MDR report key: 4150618 · Received October 8, 2014

    Report

    Report Number
    8041101-2014-00043
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 22, 2014
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2014, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (REACH J&J FLOSS WAXED 55YD). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2014 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH LIST DENTOTAPE 20M FROM 3 14 (ROUTE DENTAL, LOT NUMBER, EXPIRATION DATE, INDICATION AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE METAL CUTTER INSIDE THE BOX FELL OUT AND SHE HAD TO USE A SCISSORS TO CUT THE TAPE. THIS REPORT HAD NO ADVERSE EVENT. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE FIELD SAMPLE WAS NOT RECEIVED TILL (B)(4) 2014 AND THE CONFIRMATION OF THE COMPLAINT WAS INCONCLUSIVE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632496 REACH LIST DENTOTAPE 20M FROM 3 14 DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 0041901037 NI

    Patients

    Seq Age Sex Outcome Treatment
    1