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

Model Number 12547440133

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Upc: (b)(4), lot number: 11220d, expiration date: na, udi: (b)(4).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).Consumer reported he bought 12 packs of listerine ultraclean mint floss.He used the floss for 8 months and there are two packs left.As the consumer didn¿t specify if the past used 10 packs of the floss are the same lot as the 2 packs left (lot 11220d captured in medwatch 8041101-2021-00002, lot 12620d captured in medwatch 8041101-2021-00001 and unknown lot, quantity 10 captured in medwatch 8041101-2021-00003 to document the past use.8041101-2021-00001: lot number 12620d, lot number 11220d, 8041101-2021-00003: lot number unknown.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 an event with listerine ultraclean mint floss 30yd usa.Consumer stated that the floss is plastic.It¿s not like string and has delayed elasticity to it.Consumer reported, damage tooth decay and cavities forming in between the teeth after eight months of using the product.Consumer visited health care professional (hcp) and hcp recommended to have two fillings performed.For further treatment, hcp recommended to switch back to yarn/string type floss.Consumer reported he bought 12 packs of listerine ultraclean mint floss.He used the floss for 8 months and there are two packs left.As the consumer didn¿t specify if the past used 10 packs of the floss are the same lot as the 2 packs left (lot 11220d captured in medwatch 8041101-2021-00002, lot 12620d captured in medwatch 8041101-2021-00001 and unknown lot, quantity 10 captured in medwatch 8041101-2021-00003 to document the past use.8041101-2021-00001- lot number 12620d.8041101-2021-00002- lot number 11220d.8041101-2021-00003 -lot number unknown.

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 april 21, 2020.If information is obtained that was not available for this follow-up 01 medwatch, an additional 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: 11122838
• MDR Text Key: 225256323
• Report Number: 8041101-2021-00002
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 012547440133
• UDI-Public: (01)012547440133(10)11220D
• 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: 01/12/2021

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: 12547440133
• Device Lot Number: 11220D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention