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 Problems Inflammation (1932); Pain (1994); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.Udi: (b)(4), upc = (01)12547440157, expiration date= ni, lot number = 34118d.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 male consumer reported and event with listerine gentle gum care floss mint on (b)(6) 2019.The consumer stated that he had to seek medical attention from his dentist to remove the crown in his implant in order to remove the floss.The dentist put back the implant after removal.The consumer is still experiencing pain in the jaw.

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 december 7, 2018.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.

Event Description

The consumer additionally reported listerine gentle gum care floss mint 50yd usa 12547440157 tends to fray or shred when used.In (b)(6) he noticed soreness around tooth #30 (implant) which was followed by slight bleeding.Consumer visited dentist on (b)(6) 2019 for an evaluation of the problem.The dentist found gingival inflammation and discovered some floss which had to be removed from under the implant.Due to the inflammation, he scheduled a second appointment on (b)(6) 2019 for a follow-up.On that exam, there was still inflammation and had been slight bleeding the day before.The dentist noted that the implant prosthesis was slightly loose.The implant was removed revealing a mass of tangled floss wrapped around the neck of the implant abutment.The floss had shredded around the neck of the implant, lodging there and causing inflammation around that tooth.An x-ray showed some signs of early bone loss, possibly related to the inflammation.The floss was removed, the implant prosthesis was reinserted.The consumer was instructed to stop using this type of floss for future hygiene in this area.This is 1 of 4 med-watches being submitted as four devices were involved in this event.See medwatches 8041101-2019-00054, 8041101-2020-00005, 8041101-2020-00006, 8041101-2020-00007.The same patient is represented in each medwatch.

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.H6: patient code 3191 refer to consumer reporting about tooth injury bleeding, tooth injury signs of early bone loss.Patient code 2687 also refers to implant prosthesis was slightly loose, implant was removed and tangled floss was observed.Additional patient code 1994 refers to soreness around tooth.This is 1 of 4 med-watches being submitted as four devices were involved in this event.See medwatches 8041101-2019-00054, 8041101-2020-00005, 8041101-2020-00006, 8041101-2020-00007.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up #2 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: 9250897
• MDR Text Key: 179400400
• Report Number: 8041101-2019-00054
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440157
• UDI-Public: (01)12547440157(10)34118D
• 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,Followup
• Report Date: 02/14/2020

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: 12547440157
• Device Lot Number: 34118D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/11/2019; 02/14/2020
• Supplement Dates FDA Received: 11/13/2019; 03/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 64