MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH DENTAL FLOSS ULTRA CLEAN 27M

Model Number 0041812731

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)(6) 2016 for a device product that is considered same/similar to a us marketed device ((b)(6) mint floss 30yd).This closes out this report unless other 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 dental floss ultra clean 27m, (route dental, lot number, frequency, indication and expiration date unspecified).After an unspecified duration, the consumer noticed that device was too tight of wheeling, therefore, it was easy to snap when using or break a cutter.The consumer had such experience continuously during device usage.This report had no adverse event and the action taken with the device was unknown.The field sample was not received till (b)(6) 2016 and confirmation of the complaint was unconfirmed.Based on the information available, the device was used for intended treatment.The analysis of device and complaint category will be managed through a monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report was considered a reportable malfunction case in the united states of america.

• Brand Name: REACH DENTAL FLOSS ULTRA CLEAN 27M
• 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: 6203831
• MDR Text Key: 63265129
• Report Number: 8041101-2016-00039
• 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
• Report Date: 12/06/2016

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: 0041812731
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1