MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH FLOSS WAXED 55YD; DENTAL FLOSS

Model Number 0041802738

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 (b)(4) 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 significant information is received.

Event Description

This spontaneous report was received on (b)(6) -2015 from a consumer (age and gender unspecified) reporting on self from (b)(4).On an unspecified date, the consumer started using reach floss waxed 55yd (route dental, lot number 0304d, expiration date, frequency and indication unspecified).After an unspecified duration, while opening the cover of the container and pulling floss, the consumer noticed that a cutter guard came off from the white container of the device.The consumer did not use it in a normal way but used the device fully.The consumer was a regular user of the device.The consumer purchased the new device and reported that old device did not have a clasp of cutter.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 on 23-feb-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 significant information is received.

Event Description

This spontaneous report was received on 25-dec-2015 from a consumer (age and gender unspecified) reporting on self from japan.On an unspecified date, the consumer started using reach floss waxed 55yd (route dental, lot number 0304d, expiration date, frequency and indication unspecified).After an unspecified duration, while opening the cover of the container and pulling floss, the consumer noticed that a cutter guard came off from the white container of the device.The consumer did not use it in a normal way but used the device fully.The consumer was a regular user of the device.The consumer purchased the new device and reported that old device did not have a clasp of cutter.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 08-feb-2016.A review of complaint data revealed no unfavorable trends for the reported lot number.Analysis for this product and complaint category will be managed through the monthly trending process.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.Based on the investigation results, there is no evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.Complaint trends will continue to be monitored.The complaint was closed with an undetermined disposition.This report remains a reportable malfunction in the united states of america.

• Brand Name: REACH FLOSS WAXED 55YD
• 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: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5373816
• MDR Text Key: 36284208
• Report Number: 8041101-2016-00004
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0041802738
• Device Lot Number: 0304D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1