MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DENTOTAPE WAXED FLOSS SLIM; DENTAL FLOSS

Model Number DWSLI84093

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This foreign report is being submitted on 12-dec-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed 55yd).This closes out this report unless additional follow up information is received.

Event Description

This spontaneous report was received on 30-nov-2016 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer started using dentotape waxed floss slim 50m, dentally (lot number 0996d, frequency, expiration date and indication unspecified).After an unspecified duration, the consumer noticed that the chopper of device fell off.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

This foreign report is being submitted 27-jan-2017 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed 55yd).This closes out this report unless additional significant follow up information is received.

Event Description

This spontaneous report was received on 30-nov-2016 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer started using dentotape waxed floss slim 50m, dentally (lot number 0996d, frequency, expiration date and indication unspecified).After an unspecified duration, the consumer noticed that the chopper of device fell off.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 14-jan-2017.A review of complaint data revealed no unfavourable trends for the reported lot number.The analysis for the product and complaint category would be managed through monthly trending process.As documented in records and retained sample review, the product met specification.Based on the investigation results, there was no evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.Complaint trends would continue to be monitored.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

This foreign report is being submitted on 22-feb-2017 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed 55yd).This closes out this report unless additional significant follow up information is received.

Event Description

This spontaneous report was received on 30-nov-2016 from a consumer (age and gender unspecified) reporting on self from norway.On an unspecified date, the consumer started using dentotape waxed floss slim 50m, dentally (lot number 0996d, frequency, expiration date and indication unspecified).After an unspecified duration, the consumer noticed that the chopper of device fell off.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 14-jan-2017.A review of complaint data revealed no unfavourable trends for the reported lot number.The analysis for the product and complaint category would be managed through monthly trending process.As documented in records and retained sample review, the product met specification.Based on the investigation results, there was no evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.Complaint trends would continue to be monitored.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.Additional information was received on 15-feb-2017.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.Product met specification was documented in the records and retain sample review.Field sample was received on 06-feb-2017 and visually evaluated on 14-feb-2017.The product received as field sample did not meet specifications as it was received with insert breakage.However, a review of the data associated with the defect was performed and no unfavorable trends were identified.The complaint investigation was closed with a disposition of confirmed.This report remains as a reportable malfunction in the united states of america.

• Brand Name: DENTOTAPE WAXED FLOSS SLIM
• 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: 6165706
• MDR Text Key: 62386071
• Report Number: 8041101-2016-00036
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DWSLI84093
• Device Lot Number: 0996D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1