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

Lot Number 3415D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 29-aug-2017 from a female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally for general oral hygiene (lot number 3415d, frequency and expiration date unspecified).With the first usage of device the consumer noticed that the little silver metal cutter was separated and did not stay in place and was hanging on by a piece of thread.The consumer had to open the lid to see the metal cutter.Consumer mentioned that plastic insert also came out with cutter.It was reported that the cutter either moved or came off and fell down on floor numerous times while using.It was reported that consumer was not able to cut the floss.By ineffective consumer referred to ineffective cutter.After an unspecified duration, the device was discontinued.This report was considered as reportable malfunction in the united states of america.

Manufacturer Narrative

The date of this submission is 27-sep-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 29-aug-2017 from a female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally for general oral hygiene (lot number 3415d, frequency and expiration date unspecified).With the first usage of device the consumer noticed that the little silver metal cutter was separated and did not stay in place and was hanging on by a piece of thread.The consumer had to open the lid to see the metal cutter.Consumer mentioned that plastic insert also came out with cutter.It was reported that the cutter either moved or came off and fell down on floor numerous times while using.It was reported that consumer was not able to cut the floss.By ineffective consumer referred to ineffective cutter.After an unspecified duration, the device was discontinued.This report was considered as reportable malfunction in the united states of america.Additional information was received on 19-sep-2017.The product code was updated from listerine ultraclean mint floss usa lsucmfus to listerine ultraclean mint floss 30yd usa 012547440133 1254744013usa.This report remains as reportable malfunction case in the united states of america.

Manufacturer Narrative

The date of this submission is 11-oct-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2017 from a female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally for general oral hygiene (lot number 3415d, frequency and expiration date unspecified).With the first usage of device the consumer noticed that the little silver metal cutter was separated and did not stay in place and was hanging on by a piece of thread.The consumer had to open the lid to see the metal cutter.Consumer mentioned that plastic insert also came out with cutter.It was reported that the cutter either moved or came off and fell down on floor numerous times while using.It was reported that consumer was not able to cut the floss.By ineffective consumer referred to ineffective cutter.After an unspecified duration, the device was discontinued.This report was considered as reportable malfunction in the united states of america.Additional information was received on 19-sep-2017.The product code was updated from listerine ultraclean mint floss usa lsucmfus to listerine ultraclean mint floss 30yd usa 012547440133 1254744013usa.This report remains as reportable malfunction case in the united states of america.Additional information was received on 04-oct-2017.A review of complaint data revealed no unfavourable trends for the reported lot number.Visual inspection was performed on the retain samples and all results met specification.Device history records were reviewed and no deviations or non-conformances were noted.Product met specification as documented in the records and retain sample reviewed.In addition, based on the investigation results, there was evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.The analysis for this product and complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction 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: 6854600
• MDR Text Key: 85622667
• Report Number: 8041101-2017-00021
• 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,Followup,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3415D
• Other Device ID Number: UDI # 012547440133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1