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

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

Patient Problems Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age, sex, weight, ethnicity and race was not provided for reporting.This report is for unknown listerine gentle gum care floss.Upc#, lot# and udi # is not available.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.Device history records review could not be completed without lot number.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00033.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The consumer alleged after using listerine gentle gum care floss, his/her gums reacted violently and got very swollen.The consumer went to a periodontist, had a tissue biopsy and almost 5 months of treatments.Consumer also alleged the symptoms came back after reintroduced the product, therefore the dentist alleged that the cinnamon in the dental floss caused the swollen gum.The consumer has not used the floss in 3 weeks and the swelling is improving.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00033.The same patient is represented in each medwatch.

• 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 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 8185460
• MDR Text Key: 131175827
• Report Number: 8041101-2018-00034
• Device Sequence Number: 1
• Product Code: JES
• 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
• Report Date: 11/30/2018

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention