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

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 04-jul-2017.This is an initial submission for the second product in this case.The manufacturer report number for this submission is 8041101-2017-00024.The manufacturer report number for the first product in this case is 8041101-2017-00023.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 18-jun-2017 from an adult consumer (age and gender unspecified) reporting on self from the united states of america via social media.The medical history and the concomitant medications were not reported.On an unspecified date, the consumer started using listerine ultraclean access dental flosser, (quantity 2) dentally for unknown indication (frequency lot number and expiration date unspecified).After an unspecified duration, the consumer noticed that the flosser broke in mouth during use and it happened for second time.The consumer stated that, during the last use it caused cut in the mouth.The action taken with the device and outcome of the event were unknown.Lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.The analysis for the product quality complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.This report was assessed as non serious and company causality was assessed as related.This report was assessed as reportable malfunction case in the united states of america.

• Brand Name: LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER
• 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: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 6685321
• MDR Text Key: 79062275
• Report Number: 8041101-2017-00024
• 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: 06/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1