MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DR LISTERINE® ULTRACLEAN® ACCESS® DENTAL FLOSSER

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of birth and weight were not provided for reporting.This report is for unknown listerine® ultraclean® access® dental flosser.Upc#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The consumer alleged that during flossing the flosser head fell out of the flosser handle and into the sink during a past use of the flosser.

• Brand Name: LISTERINE® ULTRACLEAN® ACCESS® DENTAL FLOSSER
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS DR; carretera sánchez km. 18.5; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7537500
• MDR Text Key: 109049934
• Report Number: 8041101-2018-00017
• 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: 04/26/2018

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1