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

Model Number 12547440133

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4), upc = (01)12547440133, expiration date= na, lot number = 3137d.The device has been returned to the manufacturer and is under evaluation/investigation and a review of the device history record has been requested.Upon visual evaluation of the returned device, it was noted that the sample was received with insert breakage with the cutter separated from insert assembly and cutter was not returned.Product was shipped to manufacturing site for further evaluations.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with listerine ultraclean mint floss 30yd usa.The consumer reported that the metal cutter and plastic insert fell off about half way through with use of the product.This is all known information at this time about this complaint.There was no adverse event reported.

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 november 7,2017.H3, h6: a manufacturing investigation was performed for the subject device, the product received as field sample does not meet specifications due to the sample was received with insert breakage.The cutter and the plastic part that was separated was not received.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.

• 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: 9489088
• MDR Text Key: 205174659
• Report Number: 8041101-2019-00060
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440133
• UDI-Public: (01)12547440133(10)3137D
• 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: 12/30/2019

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: 3137D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 01/02/2020
• Patient Sequence Number: 1