MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN MINT FLOSS 30YD; DENTAL FLOSS

Model Number 1254744013

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on 24-nov-2014 from an adult consumer (age and gender unspecified) reporting on self from the united states.On an unspecified date, the consumer started using listerine ultraclean mint floss (route-dental frequency, lot number and expiration date unspecified) for unknown indication.On the first day the floss was used, the metal tab inside used to cut the floss, fell out or became loose.The consumer had to put it back each time they opened the case.This report had no adverse event.The action taken with the device was unknown.This report was considered a reportable malfunction in the united states.

Manufacturer Narrative

The date of this submission is 05-dec-2014.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is 15-jan-2015.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2014 from an adult consumer (age and gender unspecified) reporting on self from the united states.On an unspecified date, the consumer started using listerine ultraclean mint floss (route-dental, frequency, lot number and expiration date unspecified) for unknown indication.On the first day the floss was used, the metal tab inside used to cut the floss, fell out or became loose.The consumer had to put it back each time the case was opened.This report had no adverse event.The action taken with the device was unknown.This report was considered a reportable malfunction in the united states.Additional information was received on 06-jan-2015.The device name was updated from listerine ultraclean mint floss usa to listerine ultraclean mint floss 30yd usa.The sample has not been received for evaluation.Manufacturing related issues were reviewed and no issues were found associated with loose cutter defect for the product reported.The device was used as intended for treatment.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.

• Brand Name: LISTERINE ULTRACLEAN MINT FLOSS 30YD
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: amal yamany ; 199 grandview road; ni; skillman, NJ 08558 ; 9089043455
• MDR Report Key: 4299228
• MDR Text Key: 16303125
• Report Number: 8041101-2014-00052
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

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: 1254744013
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Removal/Correction Number: NI
• Patient Sequence Number: 1