MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE GENTLE GUM CARE MINT FLOSS; DENTAL FLOSS

Model Number 1254744022

Patient Problems Dysphagia/ Odynophagia (1815); Swelling (2091); Urticaria (2278)

Event Date 03/23/2015

Event Type  Injury  

Event Description

This spontaneous report was received on (b)(6) 2015 from a (b)(6)-year-old female dentist reporting on self from the united states.The medical history included high blood pressure.The concomitant medication included unspecified medication to treat high blood pressure.Her reported weight was 90 kilograms.On (b)(6) 2015, the consumer used listerine gentle gum care mint floss (route- dental; lot number 1614d, expiration date unspecified) small length-size, once to remove the food stuck between her upper right tooth numbers three and four.Immediately, she noticed that her tongue began to feel strange and she developed hives on the right side of her tongue.On the same day, her tongue swelled up double its size and she then went to the hospital.By the time she reached, her tongue doubled its size again and she could barely breathe and swallow through mouth.She was administered with an unspecified shot in her mouth to lessen the swelling and was prescribed with unknown steroids (dose, frequency and route unspecified) for ten days to treat the events.She stated that she had used the floss from the same container in the past without untoward events.She did not use the device further.In the afternoon of the next day, the events resolved.This report was assessed as serious (required intervention) and company causality was assessed as related.

Manufacturer Narrative

The date of this submission is (b)(4) 2015.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

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 caucasian female dentist reporting on self from the united states.The medical history included high blood pressure.The concomitant medication included unspecified medication to treat high blood pressure.Her reported weight was (b)(6) kilograms.On (b)(6)-2015, the consumer used listerine gentle gum care mint floss (route- dental; lot number 1614d, expiration date unspecified) small length-size, once to remove the food stuck between her upper right tooth numbers three and four.Immediately, she noticed that her tongue began to feel strange and she developed hives on the right side of her tongue.On the same day, her tongue swelled up double its size and she then went to the hospital.By the time she reached, her tongue doubled its size again and she could barely breathe and swallow through mouth.She was administered with an unspecified shot in her mouth to lessen the swelling and was prescribed with unknown steroids (dose, frequency and route unspecified) for ten days to treat the events.She stated that she had used the floss from the same container in the past without untoward events.She did not use the device further.In the afternoon of the next day, the events resolved.This report was assessed as serious (required intervention) and company causality was assessed as related.Additional information was received on 07-may-2015.The product code was updated from listerine gentle gum care floss mint 50yd usa 012547440157 1254744015usa to listerine gentle gum care floss mint 5yd prof usa 012547440225 1254744022usa.A review of the data revealed no unfavorable trend for the reported lot number.The retained sample was visually evaluated and did not present any defects.All product components (cutter, insert, bobbin and dispenser) were in good condition.The device history records were reviewed and no issues, defects or investigations were created related to a defect.Manufacturing related issues were reviewed and no issues were found associated with the adverse event.The product label states that it contains cinnamon.The complaint investigation was closed with a disposition of undetermined.The device was used for treatment.Complaint trends will continue to be monitored.This report remains serious.

• Brand Name: LISTERINE GENTLE GUM CARE MINT FLOSS
• 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: jijo james ; 410 george road; ni; new brunswick, NJ 08901 ; 7325246620
• MDR Report Key: 4700945
• MDR Text Key: 5649125
• Report Number: 8041101-2015-00013
• 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,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

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: Health Professional
• Device Model Number: 1254744022
• Device Lot Number: 1614D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED HIGH BLOOD PRESSURE MEDICATION
• Patient Outcome(s): Required Intervention
• Patient Weight: 90