MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC LISTERINE GENTLE GUM CARE FLOSS MINT; DENTAL FLOSS

Model Number 12547440157

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

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age, weight, ethnicity and race was not provided for reporting.(b)(4).Expiration date= ni.Lot number = 16419d.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.(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 gentle gum care floss mint 50yd.When flossing her teeth with listerine gentle gum care, the floss shredded between the consumer¿s teeth.The consumer needed an office visit to the dentist to have the floss removed from between her teeth.The consumer¿s symptoms have resolved.

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 amp; 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 amp; johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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) 2019.Tensile results were reviewed and were found acceptable.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 GENTLE GUM CARE FLOSS MINT
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558
• MDR Report Key: 9445290
• MDR Text Key: 185524333
• Report Number: 8041101-2019-00056
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440157
• UDI-Public: (01)12547440157(10)16419D
• 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: 12/19/2019

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: 12547440157
• Device Lot Number: 16419D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention