BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON FLOSS, MINT WAXED

    MDR report key: 3152746 · Received June 8, 2013

    Report

    Report Number
    8041101-2013-00029
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 27, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 26-JUN-2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 27-MAY-2013 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 2691DOU, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). THE CONSUMER WAS USING THE DEVICE FROM QUITE A TIME AND STATED THAT WHILE PULLING THE STRING OUT THE WHOLE DEVICE USE TO COME OUT AND IT WOULD NOT STAY ATTACHED INSTEAD THE ENTIRE BROKEN PART USE TO COME OUT OF THE CONTAINER. THE CONSUMER NOTICED THAT THE METAL CUTTER BROKE AND THE PLASTIC INSERT THAT HOLDS THE SPOOL OF FLOSS POPPED OUT AND THE ROLL KEPT COMING OUT WHENEVER THE CONSUMER PULLED A PIECE OF THE FLOSS. THE CONSUMER TRIED SEVERAL TIMES TO REINSERT THE ROLL BACK INTO THE CONTAINER STILL WAS NOT ABLE TO DISPENSE THE FLOSS PROPERLY. IT WAS ALSO STATED THAT THE CONTAINER WAS NOT BROKEN NOR IT WAS FALLING APART WHEN THE PACKAGE WAS OPENED FIRST. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT REVEALED NO ADVERSE TRENDS AND NO TREND INVOLVING LOT NUMBER 2691D. A REVIEW OF THE HISTORY OF CHANGES, RETAINED SAMPLE EVALUATION AND DEVICE HISTORY RECORD DID NOT INDICATE THAT THE DEVICE REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED FAILED TO MEET SPECIFICATIONS. FIELD SAMPLE WAS EVALUATED AND PRESENTED THE LOOSE CUTTER. THE CORRECTIVE ACTIONS WERE DIRECTED TO THE POTENTIAL STRESS DURING SHIPMENT OF THE CUTTER PART. THE SHIPMENT CONFIGURATION WAS CHANGED FROM (B)(4) PER SHIPPING CASE AND ADDED TUBULAR CORRUGATE ATOP THE PALLETS TO ELIMINATE THE TRUCKING EFFECT OF DOUBLE STACKING. THIS ACTION WOULD PROVIDE ADEQUATE CONTROLS ON THE PREVENTION OF STRESSED CUTTERS THAT CAN BECOME LOOSE DURING THE ASSEMBLY. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED AS INTENDED FOR TREATMENT. THE DISPOSITION FOR THE COMPLAINT WAS CONFIRMED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 2691DOU, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). THE CONSUMER WAS USING THE DEVICE FROM QUITE A TIME AND STATED THAT WHILE PULLING THE STRING OUT THE WHOLE DEVICE USE TO COME OUT AND IT WOULD NOT STAY ATTACHED INSTEAD THE ENTIRE BROKEN PART USE TO COME OUT OF THE CONTAINER. THE CONSUMER NOTICED THAT THE METAL CUTTER BROKE AND THE PLASTIC INSERT THAT HOLDS THE SPOOL OF FLOSS POPPED OUT AND THE ROLL KEPT COMING OUT WHENEVER THE CONSUMER PULLED A PIECE OF THE FLOSS. THE CONSUMER TRIED SEVERAL TIMES TO REINSERT THE ROLL BACK INTO THE CONTAINER STILL WAS NOT ABLE TO DISPENSE THE FLOSS PROPERLY. IT WAS ALSO STATED THAT THE CONTAINER WAS NOT BROKEN NOR IT WAS FALLING APART WHEN THE PACKAGE WAS OPENED FIRST. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 2691DOU, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). THE CONSUMER WAS USING THE DEVICE FROM QUITE A TIME AND STATED THAT WHILE PULLING THE STRING OUT THE WHOLE DEVICE USE TO COME OUT AND IT WOULD NOT STAY ATTACHED INSTEAD THE ENTIRE BROKEN PART USE TO COME OUT OF THE CONTAINER. THE CONSUMER NOTICED THAT THE METAL CUTTER BROKE AND THE PLASTIC INSERT THAT HOLDS THE SPOOL OF FLOSS POPPED OUT AND THE ROLL KEPT COMING OUT WHENEVER THE CONSUMER PULLED A PIECE OF THE FLOSS. THE CONSUMER TRIED SEVERAL TIMES TO REINSERT THE ROLL BACK INTO THE CONTAINER STILL WAS NOT ABLE TO DISPENSE THE FLOSS PROPERLY. IT WAS ALSO STATED THAT THE CONTAINER WAS NOT BROKEN NOR IT WAS FALLING APART WHEN THE PACKAGE WAS OPENED FIRST. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE LOT NUMBER WAS UPDATED FROM 2691DOU TO 2691D. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257296 JOHNSON & JOHNSON FLOSS, MINT WAXED DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137009217 2691D

    Patients

    Seq Age Sex Outcome Treatment
    1