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

Model Number 12547440133

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.Upc: (b)(4); lot number: 29119d; expiration date: na; udi: (b)(4).Device has been returned to the manufacturer, and is under evaluation/investigation; a review of the device history record has been requested.Upon visual evaluation of the one returned device, it was noted that the metal cutter was completely separated from the container.Product was shipped to manufacturing site for further evaluations.(b)(4).This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 8041101-2020-00020.The same consumer is represented in each medwatch.If information is obtained that was not available for the initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

A male consumer reported an event with listerine ultraclean mint floss.The consumer stated that for the second time the packaging has failed.Specifically, the metal cutter piece has come detached from the floss holder, making it impossible to cut the floss.It was impossible to use in the normal fashion.This event occurred during use and there was no adverse event reported.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch: 8041101-2020-00020.The same consumer 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.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 october 18, 2019.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.This is 1 of 2 follow-up med-watches being submitted as two devices were involved in this event.See medwatch 8041101-2020-00020.The same consumer is represented in each medwatch.If information is obtained that was not available for the follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LISTERINE ULTRACLEAN MINT FLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08558 9418
• MDR Report Key: 10934323
• MDR Text Key: 219346583
• Report Number: 8041101-2020-00019
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440133
• UDI-Public: (01)12547440133(10)29119D
• 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: 12/16/2020

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: 12547440133
• Device Lot Number: 29119D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Event Location: Other
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1