MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER

Model Number LSUCAFUS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is (b)(6) 2015.This closes out this report unless other 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 the united states of america.On an unspecified date, the consumer started using the (b)(6) dental flosser (route: dental, frequency, lot number and expiration date unspecified) for flossing as usual and the consumer noticed that the head of the flosser broke right at the neck of the brush during the usage.This report had no adverse event and the action taken with the device was unknown.This report was considered as a reportable malfunction case in the united states of america.

Manufacturer Narrative

The date of this submission is 21-oct-2015.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 18-aug-2015 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using the listerine ultraclean access dental flosser (route: dental, frequency, lot number and expiration date unspecified) for flossing as usual and the consumer noticed that the head of the flosser broke right at the neck of the brush during the usage.This report had no adverse event and the action taken with the device was unknown.This report was considered as a reportable malfunction case in the united states of america.Additional information was received on 29-sep-2015.The device was used for general oral hygiene.The product and lot number was not reported and the returned sample was not received for evaluation.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 a reportable malfunction case in the united states of america.

• Brand Name: LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal 12345 ; DR 12345
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal 12345 ; DR 12345
• Manufacturer Contact: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5059658
• MDR Text Key: 25114523
• Report Number: 8041101-2015-00028
• 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
• Report Date: 08/18/2015

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: LSUCAFUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1