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

Model Number 12547440133

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.(b)(4).Lot number = 21918d.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.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A (b)(6) years old female consumer reported and event while using listerine ultraclean mint floss 30yd usa 12547440133.The consumer reported the product has too much wax on the floss and it leaves clumps in her mouth and between her teeth.The consumer revealed teeth infection.The consumer went to a healthcare professional and was prescribed an unspecified medication to treat the teeth infection.The consumer is no longer experiencing any symptoms.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: 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 august 7, 2018.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: LISTERINE ULTRACLEAN MINT FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558
• MDR Report Key: 9637479
• MDR Text Key: 190015457
• Report Number: 8041101-2020-00003
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440133
• UDI-Public: (01)12547440133(10)21918D
• 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,Followup
• Report Date: 02/16/2020

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: 12547440133
• Device Lot Number: 21918D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/16/2020
• Supplement Dates FDA Received: 02/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82