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

Model Number 012547440188

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.(b)(4).No known impact or consequence to patient ¿ consumer did not allege any injuries as a result of the product malfunction.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 (b)(6) 2017.If information is obtained that was not available for this 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.

• Brand Name: LISTERINE® ULTRACLEAN® ACCESS® DENTAL FLOSSER
• 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; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7537447
• MDR Text Key: 109048631
• Report Number: 8041101-2018-00016
• 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
• Device Model Number: 012547440188
• Device Lot Number: 1377D
• Other Device ID Number: (01)012547440188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Event Location: Other
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1