BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON & JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS

    MDR report key: 3141340 · Received June 3, 2013

    Report

    Report Number
    8041101-2013-00027
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 29-JUL-2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    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 (B)(4) 2013 FROM A (B)(6) AFRICAN-AMERICAN, FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE CONSUMER HAD SEASONAL ALLERGIES. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING JOHNSON AND JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS, IN STANDARD AMOUNT, SIX TO EIGHT INCHES LONG, TWICE A DAY NORMALLY, TO GET A POPCORN KERNEL OUT FROM HER TEETH (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, WHEN SHE USED THE FLOSS TO GET THE KERNEL OUT, IT GOT STUCK UNDERNEATH THE CORN KERNEL AND WHEN SHE PULLED THE FLOSS THROUGH, IT CRACKED BOTH TEETH ON EITHER SIDE. AFTER AN UNSPECIFIED DURATION, SHE WAS EXAMINED BY HER DENTIST AND HAD AN X-RAY, WHO TOLD HER THAT SHE WOULD HAVE TWO CROWNS PUT IN. SHE ALSO STATED THAT THE LOT NUMBER ON THE PACKAGE WAS FADED. AFTER AN UNSPECIFIED DURATION, USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE CONSUMER CONSULTED A DENTIST AND WAS DIAGNOSED WITH CRACKED TOOTH ON WHICH A CROWN WAS PUT IN. AFTER TWELVE DAYS ON (B)(6) 2013, THE EVENT RESOLVED. THIS REPORT REMAINS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE).

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE CONSUMER HAD SEASONAL ALLERGIES. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING JOHNSON AND JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS, IN STANDARD AMOUNT, SIX TO EIGHT INCHES LONG, TWICE A DAY NORMALLY, TO GET A POPCORN KERNEL OUT FROM HER TEETH (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, WHEN SHE USED THE FLOSS TO GET THE KERNEL OUT, IT GOT STUCK UNDERNEATH THE CORN KERNEL AND WHEN SHE PULLED THE FLOSS THROUGH, IT CRACKED BOTH TEETH ON EITHER SIDE. AFTER AN UNSPECIFIED DURATION, SHE WAS EXAMINED BY HER DENTIST AND HAD AN X-RAY, WHO TOLD HER THAT SHE WOULD HAVE TWO CROWNS PUT IN. SHE ALSO STATED THAT THE LOT NUMBER ON THE PACKAGE WAS FADED. AFTER AN UNSPECIFIED DURATION, USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 17-MAY-2013 FROM A (B)(6), AFRICAN-AMERICAN, FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE CONSUMER HAD SEASONAL ALLERGIES. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING JOHNSON AND JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS, IN STANDARD AMOUNT, SIX TO EIGHT INCHES LONG, TWICE A DAY NORMALLY, TO GET A POPCORN KERNEL OUT FROM HER TEETH (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, WHEN SHE USED THE FLOSS TO GET THE KERNEL OUT, IT GOT STUCK UNDERNEATH THE CORN KERNEL AND WHEN SHE PULLED THE FLOSS THROUGH, IT CRACKED BOTH TEETH ON EITHER SIDE. AFTER AN UNSPECIFIED DURATION, SHE WAS EXAMINED BY HER DENTIST AND HAD AN X-RAY, WHO TOLD HER THAT SHE WOULD HAVE TWO CROWNS PUT IN. SHE ALSO STATED THAT THE LOT NUMBER ON THE PACKAGE WAS FADED. AFTER AN UNSPECIFIED DURATION, USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON 14-JUN-2013 THE CONSUMER CONSULTED A DENTIST AND WAS DIAGNOSED WITH CRACKED TOOTH ON WHICH A CROWN WAS PUT IN. AFTER TWELVE DAYS ON (B)(6) 2013, THE EVENT RESOLVED. THIS REPORT REMAINS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). ADDITIONAL INFORMATION RECEIVED ON 25-JUN-2013. LOT NUMBER WAS NOT PROVIDED AND NO SAMPLE HAD BEEN RECEIVED. THE INVESTIGATION WAS PERFORMED FOR THE FAMILY OF REACH J AND J FLOSS CLEAN BURST SPEARMINT WITHOUT A LOT NUMBER. THE PRODUCT FAMILY REACH J AND J FLOSS CLEAN BURST SPEARMINT COUNT TRENDING OF THE LAST 24 MONTHS DID NOT SHOW ADVERSE TRENDS. DISPOSITION WAS UNDETERMINED. THIS REPORT REMAINS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE).

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) , (B)(6) , FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE CONSUMER HAD SEASONAL ALLERGIES. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING JOHNSON AND JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS, IN STANDARD AMOUNT, SIX TO EIGHT INCHES LONG, TWICE A DAY NORMALLY, TO GET A POPCORN KERNEL OUT FROM HER TEETH (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, WHEN SHE USED THE FLOSS TO GET THE KERNEL OUT, IT GOT STUCK UNDERNEATH THE CORN KERNEL AND WHEN SHE PULLED THE FLOSS THROUGH, IT CRACKED BOTH TEETH ON EITHER SIDE. AFTER AN UNSPECIFIED DURATION, SHE WAS EXAMINED BY HER DENTIST AND HAD AN X-RAY, WHO TOLD HER THAT SHE WOULD HAVE TWO CROWNS PUT IN. SHE ALSO STATED THAT THE LOT NUMBER ON THE PACKAGE WAS FADED. AFTER AN UNSPECIFIED DURATION, USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON 14-JUN-2013 THE CONSUMER CONSULTED A DENTIST AND WAS DIAGNOSED WITH CRACKED TOOTH ON WHICH A CROWN WAS PUT IN. AFTER TWELVE DAYS ON (B)(6) 2013, THE EVENT RESOLVED. THIS REPORT REMAINS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). ADDITIONAL INFORMATION RECEIVED ON 25-JUN-2013 LOT NUMBER WAS NOT PROVIDED AND NO SAMPLE HAD BEEN RECEIVED. THE INVESTIGATION WAS PERFORMED FOR THE FAMILY OF REACH J AND J FLOSS CLEAN BURST SPEARMINT WITHOUT A LOT NUMBER. THE PRODUCT FAMILY REACH J AND J FLOSS CLEAN BURST SPEARMINT COUNT TRENDING OF THE LAST 24 MONTHS DID NOT SHOW ADVERSE TRENDS. DISPOSITION WAS UNDETERMINED. THIS REPORT REMAINS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). ADDITIONAL INFORMATION RECEIVED ON 09-JUL-2013 FROM THE DENTIST: THE MEDICAL HISTORY ALSO INCLUDED ALLERGY TO FLAGYL (METRONIDAZOLE). ON 16-MAY-2013, THE CONSUMER PRESENTED TO A DENTIST WITH GINGIVAL IRRITATION BETWEEN TOOTH NUMBERS 30 AND 31. SHE HAD POPCORN OR A FOREIGN BODY STUCK WHICH SHE TRIED TO FLOSS OUT. SHE HAD A PERI-APICAL RADIOGRAPH AND AN INTRA-ORAL PHOTOGRAPH ON (B)(6) 2013 WHICH SHOWED THAT TOOTH NUMBER 31 HAD PFM CROWN WITH FRACTURED CERAMIC ON THE OCCLUSAL AND MESIAL SURFACE AND TOOTH NUMBER 30 WAS ALSO SENSITIVE TO CHEWING. THE DENTIST RECOMMENDED HER PERIOGARD IRRIGATION AND A NEW CROWN ON TOOTH NUMBER 31 AND RE-EVALUATION FOR TOOTH NUMBER 30. SHE HAD REPLACEMENT OF CROWN DONE ON TOOTH NUMBER 31 ON (B)(6) 2013. THE DENTIST MENTIONED THAT HE COULD NOT DETERMINE WHEN OR HOW THE CROWN CHIPPED AND HENCE, ASSESSED IT AS NOT RELATED TO THE DEVICE. THIS REPORT REMAINS SERIOUS (SIGNIFICANT DISABILITY - PERMANENT DAMAGE TO BODY STRUCTURE). THE COMPANY CAUSALITY REMAINS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244512 JOHNSON & JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS REFCBSUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability