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

Model Number 12547440225

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

Patient Problems Swelling (2091); Reaction (2414)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ethnicity/race were not provided for reporting.Udi: (b)(4).Upc = (b)(4).Expiration date= na.Lot number = (10)0958d.Device is not expected to be returned for manufacturer review/investigation.(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A husband reported that his (b)(6) wife had an immediate severe allergic reaction of swollen throat, lips and uvula after one use of listerine gentle gum care floss on (b)(6) 2018.The consumer, at first, treated the symptoms with benadryl (2 tablets, 50 mg total).The consumer went to er and was treated with steroids, antihistamine and nebulizer.Consumer is still experiencing the symptoms.

Manufacturer Narrative

Device was used for treatment, not diagnosis.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 05,2018.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• 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: 8137175
• MDR Text Key: 129451559
• Report Number: 8041101-2018-00032
• 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,Followup
• Report Date: 12/16/2018

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
• Device Model Number: 12547440225
• Device Lot Number: 0958D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 69