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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  No Answer Provided  

Event Description

I purchased what appeared to be johnson & johnson listerine gentle gum care mint floss at a (b)(6) located at (b)(6) on (b)(6) 2019.I understand this (b)(6) was recently purchased by (b)(6).I had an allergic reaction to the item.The packaging of the item suggests it may not be an item made in the united states.(b)(4).

• Brand Name: JOHNSON AND JOHNSON LISTERINE GENTLE GUM CARE MINT FLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.
• MDR Report Key: 8758084
• MDR Text Key: 150153650
• Report Number: MW5087794
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/26/2019

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1