MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE FLOSS PRODUCTS; DENTAL FLOSS

Model Number LSFUNSUS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Manufacturer Narrative

The date of this submission is 28-dec-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) female consumer reporting on self from the united states of america.The consumer did not have any known medical history and was not taking any concomitant medications.The reported weight of the consumer was (b)(6) kilograms.On an unspecified date in 2015, the consumer started using listerine dental floss unspecified, for an unknown indication (lot number and expiration date unspecified).After an unspecified duration in 2015, her mouth began to bleed.She also vomited blood and her tooth feel out approximately a week prior to reporting.On the same day, she went to the emergency room but she was not given any treatment by the doctor.Initially, she stated the product was the box with a string (floss) but then she said it was toothpaste.She had similar experience in the past with listerine's little box with a string.The action taken with the device was unknown.The events were resolving.The complaint investigation was closed with a disposition of undetermined.This report was assessed as serious (permanent disability) and company causality for the events mouth bled and tooth fell out was assessed as related and vomiting blood was assessed as not related.

• Brand Name: LISTERINE FLOSS PRODUCTS
• 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: 5328733
• MDR Text Key: 34384196
• Report Number: 8041101-2015-00036
• 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: Initial
• Report Date: 12/08/2015

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: LSFUNSUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/28/2015
• 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; Disability
• Patient Weight: 47