MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS FLOSS / TAPE AP; 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 11-jan-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 (b)(6).On an unspecified date, the consumer started using reach floss waxed 55yd (route dental, lot number, expiration date, frequency and indication unspecified).After an unspecified duration, the consumer noticed that a cutter came off from the container when the device was used.This report had no adverse event and the action taken with the device was unknown.The lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.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.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

This foreign report is being submitted on 01-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 (b)(6).On an unspecified date, the consumer started using reach floss waxed 55yd (route dental, lot number, expiration date, frequency and indication unspecified).After an unspecified duration, the consumer noticed that a cutter came off from the container when the device was used.This report had no adverse event and the action taken with the device was unknown.The lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.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.This report was considered a reportable malfunction in the united states of america.Additional information was received on 11-jan-2016.Based on quality investigation, the device was used for intended treatment.This report remains a reportable malfunction case in the united states of america.

• Brand Name: FLOSS / TAPE AP
• 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: 5356535
• MDR Text Key: 35493898
• Report Number: 8041101-2016-00002
• 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

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/25/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1