MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS

Model Number REFWMTUS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is (b)(6) 2016.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 consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed dentally for oral hygiene (lot number 2143d, frequency, expiration date unspecified).When the consumer opened the lid, the metal cutter was intact.After an unspecified duration, while dispensing, the metal cutter broke off completely from plastic insert inside the container.The consumer mentioned they used scissors to cut the floss.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 10-nov-2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 20-sep-2016 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed dentally for oral hygiene (lot number 2143d, frequency, expiration date unspecified).When the consumer opened the lid, the metal cutter was intact.After an unspecified duration, while dispensing, the metal cutter broke off completely from plastic insert inside the container.The consumer mentioned they used scissors to cut the floss.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.Additional information was received on 31-oct-2016.A review of the data revealed no unfavourable trends for the reported lot number.Device history records were reviewed and no deviations or non-conformances were noted.Visual inspection was performed on the retained samples and all results met specification.Product met specification as documented in the records and retained sample reviewed.Based on the information available, the device was used for intended treatment.The analysis of product and complaint category will be managed through a monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains no adverse event.This report remains a reportable malfunction case in the united states of america.

• Brand Name: JOHNSON AND JOHNSON FLOSS, MINT WAXED
• 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: 6010139
• MDR Text Key: 56930410
• Report Number: 8041101-2016-00026
• 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
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REFWMTUS
• Device Lot Number: 2143D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1