MAUDE Adverse Event Report: DOMINICAN REPUBLIC JOHNSON & JOHNSON REACH® CLEAN BURST¿ CINNAMON DENTAL FLOSS

Model Number REFCBCUS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 05-oct-2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 16-sep-2016 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson reach clean burst cinnamon dental floss dentally, for unknown indication (lot number 3307d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that the metal thing that cuts the floss popped 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

The date of this submission is 11-nov-2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 16-sep-2016 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson reach clean burst cinnamon dental floss dentally, for unknown indication (lot number 3307d,frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that the metal thing that cuts the floss popped 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 12-oct-2016.After an unspecified duration, the consumer threw the floss away, hence the floss was discontinued.A review of the data revealed no unfavourable trends for the reported lot number.Device history records were reviewed and no deviations or non-conformances were noted.The retained sample for this product lot had been discarded according to retention procedures and could not be evaluated as part of this complaint investigation.Product met specification as documented in the records.Based on the information available, the device was used for intended treatment.The analysis of product 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 remains no adverse event case.This report remains a reportable malfunction case in the united states of america.

• Brand Name: JOHNSON & JOHNSON REACH® CLEAN BURST¿ CINNAMON DENTAL FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): DOMINICAN REPUBLIC; unknown; san cristobal ; DR
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; unknown; ni; san cristobal ; DR
• Manufacturer Contact: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 5998978
• MDR Text Key: 56450854
• Report Number: 8041101-2016-00024
• 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: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REFCBCUS
• Device Lot Number: 3307D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1