MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE COOL MINT MINT FLOSS; DENTAL FLOSS

Model Number LSCMFLUS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 06-nov-2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 08-oct-2016 from a consumer (age and gender unspecified) reporting on self from the united states of america via social media.On an unspecified date, the consumer started using listerine cool mint floss dentally for unknown indication (frequency, lot number and expiration date unspecified).After an unspecified duration, the consumer noticed that cutter was broken.This report had no adverse event and the action taken with the device was unknown.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 for the product complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.Based on the information available at this time it cannot be determine that the device was used as intended for treatment.This report was considered a reportable malfunction in the united states of america.

• Brand Name: LISTERINE COOL MINT MINT FLOSS
• 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: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 6082270
• MDR Text Key: 59361726
• Report Number: 8041101-2016-00029
• 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: 10/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LSCMFLUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1