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

Lot Number 3225D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 24-aug-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 11-aug-2017 from a consumer (age and gender unspecified) reporting on self from the united states of america.On (b)(6) 2017, the consumer started using listerine healthy white mint floss dentally (lot number 3225d, frequency, indication and expiration date unspecified).On the same day, the consumer noticed that package came apart while getting the floss out and the floss reel on bathroom floor.It was reported that the consumer had to open the lid to see metal cutter and noticed that the metal cutter was not intact.The metal cutter broke off completely from the plastic insert inside the container while pulling the floss.The consumer put the plastic insert back into the container and was able to dispense the floss properly.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

The date of this submission is 29-sep-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 consumer (age and gender unspecified) reporting on self from the united states of america.On (b)(6) 2017, the consumer started using listerine healthy white mint floss dentally (lot number 3225d, frequency, indication and expiration date unspecified).On the same day, the consumer noticed that package came apart while getting the floss out and the floss reel on bathroom floor.It was reported that the consumer had to open the lid to see metal cutter and noticed that the metal cutter was not intact.The metal cutter broke off completely from the plastic insert inside the container while pulling the floss.The consumer put the plastic insert back into the container and was able to dispense the floss properly.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.Initial submitted report is being resubmitted to correct the action taken with the device.After an unspecified duration in (b)(6) 2017, the device was discontinued.This report was considered a reportable malfunction in the united states of america.Additional information was received on 22-sep-2017.A review of complaint data revealed no unfavorable 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.Based on the information available, the device was used for intended treatment.The analysis for the 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.

Manufacturer Narrative

The date of this submission is 07-sep-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 consumer (age and gender unspecified) reporting on self from the united states of america.On (b)(6) 2017, the consumer started using listerine healthy white mint floss dentally (lot number 3225d, frequency, indication and expiration date unspecified).On the same day, the consumer noticed that package came apart while getting the floss out and the floss reel on bathroom floor.It was reported that the consumer had to open the lid to see metal cutter and noticed that the metal cutter was not intact.The metal cutter broke off completely from the plastic insert inside the container while pulling the floss.The consumer put the plastic insert back into the container and was able to dispense the floss properly.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.Initial submitted report is being resubmitted to correct the action taken with the device.After an unspecified duration in (b)(6) 2017, the device was discontinued.This report was considered a reportable malfunction in the united states of america.

• Brand Name: LISTERINE HEALTHY WHITE 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
• Manufacturer Contact: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 6816296
• MDR Text Key: 83694985
• Report Number: 8041101-2017-00031
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3225D
• Other Device ID Number: UDI # 012547440140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1