MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON & JOHNSON REACH CLEANBURST ICE SPEARMINT WAXED FLOSS; DENTAL FLOSS

Model Number 6260020036

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Tooth Fracture (2428); Foreign Body In Patient (2687)

Event Date 12/13/2015

Event Type  Injury  

Manufacturer Narrative

This foreign report is being submitted on 28-dec-2015 for a device product that is considered same/similar to a us marketed device (reach j&j floss clean burst sprmnt (b)(4)).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2015 from a (b)(6) female consumer reporting on self from (b)(6).The medical history included fibromyalgia and vitamin b12 deficiency.The concomitant medications included b12 vitamin (cyanocobalamin) one daily for one year for vitamin b12 deficiency and lyrica (pregabalin) 75 milligrams, one daily for three or four years for fibromyalgia.The weight of the consumer was 66 kilograms.On (b)(6) 2015, the consumer started using johnson and johnson reach cleanburst ice spearmint waxed floss, to clean between her teeth, once a day.The floss was use only three times at night for dental hygiene (route dental, lot number 3401d and expiration date unspecified).While using the floss for the third time on (b)(6) 2015, it got stuck between the teeth of the consumer and the floss was not used any further.When she pulled the floss it broke her top left canine tooth in half.She stated that the broken tooth had previously been worked on with cement.She also stated that the floss was too thick to be used between the teeth.On an unspecified date, the consumer consulted the dentist who took an x-ray of the tooth and gave her an estimate to fix the tooth.She was yet to be treated for the event.The event floss stuck between teeth resolved while the event for the broken tooth did not resolve.This report was assessed as serious (medically significant) and company causality was assessed as related.

Manufacturer Narrative

This foreign report is being submitted on 09-feb-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss clean burst sprmnt 55yd).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2015 from a (b)(6)-year-old female consumer reporting on self from (b)(6).The medical history included fibromyalgia and vitamin b12 deficiency.The concomitant medications included b12 vitamin (cyanocobalamin) one daily for one year for vitamin b12 deficiency and lyrica (pregabalin) 75 milligrams, one daily for three or four years for fibromyalgia.The weight of the consumer was 66 kilograms.On (b)(6) 2015, the consumer started using johnson and johnson reach cleanburst ice spearmint waxed floss, to clean between her teeth, once a day.The floss was used only three times at night for dental hygiene (route dental, lot number 3401d and expiration date unspecified).While using the floss for the third time on (b)(6) 2015, it got stuck between the teeth of the consumer and the floss was not used any further.When she pulled the floss it broke her top left canine tooth in half.She stated that the broken tooth had previously been worked on with cement.She also stated that the floss was too thick to be used between the teeth.On an unspecified date, the consumer consulted the dentist who took an x-ray of the tooth and gave her an estimate to fix the tooth.She was yet to be treated for the event.The event floss stuck between teeth resolved while the event for the broken tooth did not resolve.This report was assessed as serious (medically significant) and company causality was assessed as related.Additional information received on 29-jan-2016.A review of the data revealed no unfavorable trends for the reported lot number.Analysis of the product and complaint category will be managed through the monthly trending process.Device history records were reviewed and no deviations or non-conformances were noted.Visual inspection was performed on the retain samples and all results met specification.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.The complaint trends will continue to be monitored.This report remains serious (medically significant).

• Brand Name: JOHNSON & JOHNSON REACH CLEANBURST ICE SPEARMINT WAXED FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal ; DR
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal ; DR
• Manufacturer Contact: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5328741
• MDR Text Key: 34384338
• Report Number: 8041101-2015-00037
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6260020036
• Device Lot Number: 3401D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/13/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 66