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

Model Number LSUCMFUS

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 04-apr-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 22-mar-2017 from a (b)(6) male consumer 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 mint floss dentally, for general gum care (general oral hygiene) (frequency, lot number and expiration date unspecified).The consumer stated that when he went to pull the floss out, the cutting device broke in half.After an unspecified duration, when he tried to get the floss out after the cutting device broke, he got cut on his hand.He stated that it happened three times as the edge of device was sharp.It was reported that the floss was not used before cutting his hand.He applied neosporin (bacitracin, neomycin, and polymyxin b) to treat the event.The consumer mentioned to have used the device in past.After an unspecified duration, the device was discontinued.The event was resolving.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.Product was used for intended treatment.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 considered a reportable malfunction case in the united states of america.

• Brand Name: LISTERINE ULTRACLEAN MINT FLOSS
• 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: 6456045
• MDR Text Key: 71836247
• Report Number: 8041101-2017-00014
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LSUCMFUS
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1