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

Model Number 12547440157

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided for reporting.Upc: (b)(4); lot number: 1868d; expiration date: na; udi: (b)(4).Device evaluation/investigation could not be completed at this time; 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, an additional follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported, the listerine gentle gum care floss mint 50yd usa 12547440157 is of poor quality container.Consumer reported while using the floss, the metal tear piece broke on top.The consumer used a scissor each time to cut the floss.There was no adverse event associated with this complaint.

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.H3, h6: a manufacturing investigation was performed for the subject device, it was confirmed that the metal cutter was completely separated from the insert assembly.It is unknown how the product was being used at the time.At this time, no conclusion is able to be drawn about the cause of the metal cutter separation as no additional information is available regarding the use of the device.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Johnson & amp; 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.D10, h3,h6: product was returned for investigation for an broken cutter.Upon visual evaluation of the returned device, it was noted that the metal cutter was completely separated from the insert assembly.It is unknown how the product was being used at the time.Additional evaluation is pending from manufacturing site.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 july 5, 2018.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LISTERINE GENTLE GUM CARE FLOSS MINT
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08558 9418
• MDR Report Key: 10824127
• MDR Text Key: 216702018
• Report Number: 8041101-2020-00018
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440157
• UDI-Public: (01)12547440157(10)1868D
• 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: 12/16/2020

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: 12547440157
• Device Lot Number: 1868D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/20/2020; 12/16/2020
• Supplement Dates FDA Received: 12/04/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1