MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH LIST FLOSS CLEANBURST 50M; DENTAL FLOSS

Model Number 0041914031

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This foreign report is being submitted as a device product that is considered same/similar to a us marketed device (listerine cool mint floss 55yd).This closes out the report unless 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 (b)(6).On an unspecified date, the consumer started using reach list floss cleanburst 50m, for dental hygiene by using it couple of times (route: dental, lot number 0085d, expiration date and frequency unspecified).After an unspecified duration, the consumer noticed that cutter snapped off when the device was used.This report had no adverse event and the action taken with the device was unknown.Till (b)(6) 2016, field sample was not received.The confirmation of this complaint was inconclusive.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

This follow up foreign report is being submitted 24-jan-2017 for a device product that is considered same/similar to a us marketed device (listerine cool mint floss 55yd).This closes out the report unless 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 (b)(6).On an unspecified date, the consumer started using reach list floss cleanburst 50m, for dental hygiene by using it couple of times (route: dental, lot number 0085d, expiration date and frequency unspecified).After an unspecified duration, the consumer noticed that cutter snapped off when the device was used.This report had no adverse event and the action taken with the device was unknown.Till 05-dec-2016, field sample was not received.The confirmation of this complaint was inconclusive.This report was considered a reportable malfunction in the united states of america.Additional information was received on 14-jan-2017.A review of the data revealed no unfavorable trends for the reported lot number.The analysis of product and complaint category will be managed through a monthly trending process.As per the records and retain 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, this device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.This report remains as a reportable malfunction in the united states of america.

Manufacturer Narrative

This foreign report is being submitted on 16-mar-2017 for a device product that is considered same/similar to a us marketed device (listerine cool mint floss 55 yd ).This closes out the report unless additional significant information is received.

Event Description

This spontaneous report was received on 01-dec-2016 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer started using reach list floss cleanburst 50 m, for dental hygiene by using it couple of times (route: dental, lot number 0085d, expiration date and frequency unspecified).After an unspecified duration, the consumer noticed that cutter snapped off when the device was used.This report had no adverse event and the action taken with the device was unknown.Till 05-dec-2016, field sample was not received.The confirmation of this complaint was inconclusive.This report was considered a reportable malfunction in the united states of america.Additional information was received on 14-jan-2017.A review of the data revealed no unfavorable trends for the reported lot number.The analysis of product and complaint category will be managed through a monthly trending process.As per the records and retain 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, this device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.This report remains as a reportable malfunction in the united states of america.Additional information received on 03-mar-2017.On 16-feb-2017, one field sample was received and evaluated.Based on the quality investigations, it was found that the field sample did not meet specifications for appearance because the sample was received with insert breakage.The device history records were reviewed and no deviations or non-conformances were noted.The visual inspection was performed on the retain samples and all results met specification.The device met specification as documented in the records and retain sample reviewed.However, the field sample did not meet specification which had been verified.In addition, based on the field sample results, there was evidence that a device malfunction occurred.However, a review of the data associated with the defect plastic insert assembly with cutter portions that broke during usage for medium size 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: REACH LIST FLOSS CLEANBURST 50M
• 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: 6197463
• MDR Text Key: 63087579
• Report Number: 8041101-2016-00038
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/01/2016

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: 0041914031
• Device Lot Number: 0085D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/25/2017; 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1