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

Model Number UPC 8137109108

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2020

Event Type  malfunction  

Event Description

I purchased a 5-pack of reach dental floss that is obviously defective as it separates during use and leaves residual cotton fibers stuck between teeth and gums.This relates to lot # 08020d.I believe the defective product can result in both inflammation and infection when used.I have reached out to the manufacturing and reported the defective product; they have acknowledged my complaint by mailing a number of coupons that would allow me to buy more of their defective products with a (b)(6) discount.Fda safety report id # (b)(4).

• Brand Name: REACH MINT WAXED DENTAL FLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER, INC.
• MDR Report Key: 10829119
• MDR Text Key: 216147958
• Report Number: MW5097788
• Device Sequence Number: 1
• Product Code: JES
• 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: 11/07/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UPC 8137109108
• Device Catalogue Number: 30043926
• Device Lot Number: 08020D
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 86