MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS FLOSS / TAPE AP; DENTAL FLOSS

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 21-mar-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss ultraclean 30yd).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on 25-feb-2016 from a reporter reporting on a consumer (age and gender unspecified) from (b)(6).On an unspecified date, the consumer started using reach dental floss ultra clean 27m (lot number and expiration date unspecified).After an unspecified duration, the consumer noticed the cutter guard came off from the device.This report had no adverse event and the action taken with the device was unknown.As the lot number was not provided, lot trend analysis, batch record review and retain sample analysis could not be performed.Based on quality investigation, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.This report was considered a reportable malfunction 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: 5514605
• MDR Text Key: 40838161
• Report Number: 8041101-2016-00011
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1