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

Lot Number 1726D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 01-sep-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 18-aug-2017 from a female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally to remove salad from in between her teeth (lot number 1726d, frequency and expiration date unspecified).The consumer had to open the lid to see the metal cutter.After an unspecified duration, few days ago in 2017, when she tried to pull the floss out before it was on the cutter, the device came apart.She mentioned that the plastic insert popped out, the metal cutter separated from the insert and the spool of floss came out.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

The date of this submission is 11-oct-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2017 from a female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally to remove salad from in between her teeth (lot number 1726d, frequency and expiration date unspecified).The consumer had to open the lid to see the metal cutter.After an unspecified duration, few days ago in 2017, when she tried to pull the floss out before it was on the cutter, the device came apart.She mentioned that the plastic insert popped out, the metal cutter separated from the insert and the spool of floss came out.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.Additional information was received on 15-sep-2017.The sample was received on 15-sep-2017 and was visually examined on 26-sep-2017.The returned sample was visually examined according to product specification and test method by appearance.The sample was compared against the visual standard of the product.One listerine ultraclean floss 30yd usa was received opened and used.Lot number 1726d was identified.The product received as field sample met specifications for appearance, therefore, the cutter insert assembly was in perfect conditions, the cutter and the insert were intact and were not loose or broken.A review of complaint data revealed no unfavorable trends for the reported lot number.The analysis for this product and complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.The report was reassessed as a not reportable product quality issue.

• Brand Name: LISTERINE ULTRACLEAN 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: 6837371
• MDR Text Key: 84625866
• Report Number: 8041101-2017-00020
• 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,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1726D
• Other Device ID Number: UDI # 012547440133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1