MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS

Model Number 8137109128

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on 21-oct-2014 from a female consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach total care plus whitening dental floss (route-dental, lot number 2172d, expiration date and frequency unspecified) for general oral health.The metal cutter broke off while the consumer was cutting the floss.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction case in the united states.

Manufacturer Narrative

The date of this submission is 03-nov-2014.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is 22-dec-2014.This closes out this report unless other additional significant information is received.

Event Description

Additional information was received on 03-dec-2014.The returned sample was received on 03-nov-2014 with a printed lot number 2172d and was visually examined.The insert inside the dispenser was broken on the edge where the cutter was attached.The field sample failed to meet specification.A review of the data revealed no trend for the reported lot number.The retained sample was visually evaluated and did not present any defect.The device history records were reviewed and no issue, defect or investigation was created related to insert breakage defect.The manufacturing related issues were reviewed, and t no issues were found associated with insert breakage defect for the lot number and product reported.The device was used as intended for treatment.Based on the investigation performed and the condition of the returned complaint sample the disposition for this complaint was confirmed.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states.

• Brand Name: REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: amal yamany ; 199 grandview road; ni; skillman, NJ 08558 ; 9089043455
• MDR Report Key: 4220239
• MDR Text Key: 5065019
• Report Number: 8041101-2014-00046
• 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: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137109128
• Device Lot Number: 2172D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Removal/Correction Number: NI
• Patient Sequence Number: 1