MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC LISTERINE ULTRACLEAN ACCESS FLOSSER; DENTAL FLOSS

Model Number 12547440188

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight, ethnicity and race was not provided for reporting.(b)(4).Lot number = 20519d, expiration date= na.Device is not expected to be returned for manufacturer review/investigation.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 jul 24, 2019.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event with listerine ultraclean access flosser starter kit usa.Consumer stated when removing the flosser between her teeth on (b)(6) 2019, the flosser removed a tooth filling.The consumer also stated her tongue was hurting after the tooth filling was removed.The consumer is seeking medical attention and intervention to resolve the event.This is all the known information at this time.

• Brand Name: LISTERINE ULTRACLEAN ACCESS FLOSSER
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9458588
• MDR Text Key: 185538157
• Report Number: 8041101-2019-00058
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440188
• UDI-Public: (01)12547440188(10)20519D
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12547440188
• Device Lot Number: 20519D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR