MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON FLOSS, WAXED; DENTAL FLOSS

Model Number 8137009213

Device Problem Break (1069)

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

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

The date of this submission is 05-oct-2015.This closes out this report unless other 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 the united states of america.The consumer did not have any known medical history.The concomitant medications were not reported.The weight of the consumer was (b)(6).On (b)(6) 2015, the consumer started using six inches of johnson and johnson floss, waxed (route: dental, lot number 3234d, expiration date unspecified), once for oral hygiene.She used the floss by wrapping some around the finger and changed the string length, so a clean part of the floss was used for each tooth.While flossing the upper left side of her jaw, the consumer noticed the floss broke between her teeth and a piece of floss got stuck next to the second molar at the upper left side of her mouth.After 30 minutes a family member removed the piece of floss with tweezers from her mouth but the molar broke and a small pebble sized piece of the tooth fell off and caused tooth pain and she was unable to eat on that side of her mouth.She gargled with a normal amount of listerine mouthwash once daily to ease the pain.She was not sure if she had a previous dental intervention like a filling on the broken tooth.She reported that the floss looked thin compared to other brands of floss.She also stated she had used the same package of floss in the past without experiencing any adverse event.On the same day, the device was discontinued.The events did not resolve.This report was assessed as serious (medically significant) and company causality was assessed as related.

Manufacturer Narrative

The date of this submission is 24-nov-2015.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 23-sep-2015 from a (b)(6) caucasian female consumer reporting on self from the united states of america.The consumer did not have any known medical history.The concomitant medications were not reported.The weight of the consumer was (b)(6).On (b)(6) 2015, the consumer started using six inches of johnson and johnson floss, waxed (route: dental, lot number 3234d, expiration date unspecified), once for oral hygiene.She used the floss by wrapping some around the finger and changed the string length, so a clean part of the floss was used for each tooth.While flossing the upper left side of her jaw, the consumer noticed the floss broke between her teeth and a piece of floss got stuck next to the second molar at the upper left side of her mouth.After 30 minutes a family member removed the piece of floss with tweezers from her mouth but the molar broke and a small pebble sized piece of the tooth fell off and caused tooth pain and she was unable to eat on that side of her mouth.She gargled with a normal amount of listerine mouthwash once daily to ease the pain.She was not sure if she had a previous dental intervention like a filling on the broken tooth.She reported that the floss looked thin compared to other brands of floss.She also stated she had used the same package of floss in the past without experiencing any adverse event.On the same day, the device was discontinued.The events did not resolve.This report was assessed as serious (medically significant) and company causality was assessed as related.Additional information was received on 05-nov-2015.A review of the lot trending data revealed no trend for the reported lot number.The retained sample was evaluated and met specifications for appearance.The field sample was not received.A review of the device history review demonstrated the product met specifications.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains serious.

• Brand Name: JOHNSON AND JOHNSON FLOSS, WAXED
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5126708
• MDR Text Key: 27413809
• Report Number: 8041101-2015-00033
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/23/2015

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: 8137009213
• Device Lot Number: 3234D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• 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: 74