MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. REACH WAXED, UNFLAVORED WAXED FLOSS; FLOSS, DENTAL

Model Number 30024909

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 02/06/2019

Event Type  Injury  

Event Description

I purchased new dental floss at a (b)(6) location.I have not had to buy a new supply for years.This supply has a bad taste.I am pretty sure the taste is not because of my oral hygiene.I regularly floss and have been doing so for many years.I have never experience a taste like this.I will probably ask for a refund but don¿t want to not say something in the chance the public is at risk.Questions? (b)(4): outside u.S, dial collect (b)(4).Purchase date: (b)(6) 2019.(b)(4).

• Brand Name: REACH WAXED, UNFLAVORED WAXED FLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.
• MDR Report Key: 8358831
• MDR Text Key: 137400161
• Report Number: MW5084160
• 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: 02/19/2019

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: No Information
• Device Model Number: 30024909
• Device Lot Number: 32018D
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR