MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON & JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS

Model Number REFWMTUS

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 johnson and johnson floss, mint waxed (route-dental, frequency, lot number and expiration date unspecified) for general oral hygiene.After an unspecified duration, the consumer noticed that the metal cutter and attached piece of plastic broke off from the insert while cutting the floss.The consumer had to open the lid to see the metal cutter.The consumer reported that the metal cutter was still intact to the piece of the plastic while it broke away from the insert.The cutter breakage included plastic insert parts.The consumer stated to have experienced this twice.This report had no adverse event and the action taken with the device was unknown.The lot number was not reported, hence a batch record review or retain analysis could not be requested nor a lot trend analysis could be performed.The analysis for the product quality complaint category will be managed through 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.

• Brand Name: JOHNSON & JOHNSON FLOSS, MINT WAXED
• 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: 5170698
• MDR Text Key: 29039939
• Report Number: 8041101-2015-00035
• 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
• Report Date: 09/29/2015

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: REFWMTUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1