MAUDE Adverse Event Report: DOMINICAN REPUBLIC JOHNSON & JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS

Model Number 8137009217

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)(4) 2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(4) 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, (lot number 2603d, frequency and expiration date unspecified) dentally for an unknown indication.After an unspecified duration, the consumer noticed the floss cutter and the top tray over the floss or the plastic insert came loose when dispensing the floss.The consumer has been using the floss for many years and had the same issue with the last three devices used.This report had no adverse event and the action taken with the device was unknown.This report was considered as a reportable malfunction in the united states of america.

Manufacturer Narrative

The date of this submission is 09-may-2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 23-mar-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, (lot number 2603d, frequency and expiration date unspecified) dentally for an unknown indication.After an unspecified duration, the consumer noticed the floss cutter and the top tray over the floss or the plastic insert came loose when dispensing the floss.The consumer has been using the floss for many years and had the same issue with the last three devices used.This report had no adverse event and the action taken with the device was unknown.This report was considered as a reportable malfunction in the united states of america.Additional information was received on 22-apr-2016.A review of complaint data revealed no unfavorable 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 retain samples and all results met specification.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states of america.

• Brand Name: JOHNSON & JOHNSON FLOSS, MINT WAXED
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): DOMINICAN REPUBLIC; unknown; san cristobal ; DR
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal ; DR
• Manufacturer Contact: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5553358
• MDR Text Key: 42036865
• Report Number: 8041101-2016-00016
• 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: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137009217
• Device Lot Number: 2603D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1