MAUDE Adverse Event Report: JOHNSON AND JOHNSON CONSUMER INC. REACH WAXED UNFLAVORED WAXED FLOSS 55 YD; FLOSS, DENTAL

Lot Number 26918D

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 03/17/2019

Event Type  malfunction  

Event Description

Opened a box of reach brand waxed, unflavored dental floss, from lot 26918d, scan code (b)(4), and found the product was excessively over-waxed, with clumps of wax on the floss.This is very inconsistent with typical product purchased for this brand and type.When trying to use it, the excessive wax would fall off and shed.Pulling the strand further to examine if this consistency was throughout the package.I did not find any lesser-wax application on the product.Attempts to mfr (and mystery who is the mfr? since it might not be johnson and johnson anymore) to inform them about the problem has not resulted in being able to notify anyone of the issue.There is no website that informs consumer how to reach a customer feedback loop for product: it seems to have been pulled: there is a problem with the product quality; there is a problem with being able to report to the mfr, that there is a product quality.And it's pretty unclear who is the mfr (no clear way to identify who is making reach branded products now?).Distributed by johnson and johnson.

• Brand Name: REACH WAXED UNFLAVORED WAXED FLOSS 55 YD
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON AND JOHNSON CONSUMER INC.
• MDR Report Key: 8444303
• MDR Text Key: 139719746
• Report Number: MW5085093
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): Y
• 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: 03/20/2019

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?: Yes
• Device Operator: No Information
• Device Lot Number: 26918D
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR