MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER

Model Number 1254744018

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 08-nov-2016.This is an initial submission for the first product in this case.The manufacturer report number for this submission is 8041101-2016-00030.The manufacturer report number for the second product in this case is 8041101-2016-00031.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2016 from a male consumer (age unspecified) reporting on self from the united states of america.The medical history and the concomitant medications were not reported.On an unspecified date, the consumer started using listerine ultraclean access dental flosser dentally, flosser head used multiple times (intentional device misuse) (indication, lot number and expiration date unspecified).After an unspecified duration, the consumer noticed that flosser head fell off in his mouth from the handle in two separate uses during flossing.It was reported that the handle did not break in both the uses.The consumer mentioned to have used flosser head multiple times and washed after each use.The action taken with the device was unknown.This report was assessed as non-serious and company causality was assessed as related.Consumer did not provide product lot number therefore, a batch record review could not be requested or a lot trend analysis performed.Based on the information available, the device was used for intended treatment.The analysis for the product complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.This report was considered a reportable malfunction in the united states of america.

• Brand Name: LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER
• Type of Device: DENTAL FLOSSER
• 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: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 6088263
• MDR Text Key: 59557900
• Report Number: 8041101-2016-00030
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1254744018
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1