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

Model Number 012547440195

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown listerine® ultraclean® access® dental flosser.Udi: (b)(4).Upc = (b)(4).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 the flosser head detached from the flosser handle during flossing.The issue happened with 5 flosser heads with unknown lot number.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Corrected data: expiration date, udi: (b)(4).Product was returned for investigation for flosser head detached during use.Upon visual evaluation, it was noted that returned flosser heads were received open/used.As per current procedure a field sample evaluation is not required, since returned field sample was classified as biological waste and are not inspected or tested.Device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on october 23,2017.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: LISTERINE® ULTRACLEAN® ACCESS® DENTAL FLOSSER REPLACEMENT HEADS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS DR; parque industrial de itabo; 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; ni; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7343028
• MDR Text Key: 103149757
• Report Number: 8041101-2018-00008
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 012547440195
• Device Lot Number: 2967D
• Other Device ID Number: (01)012547440195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1