REACH WAXED UNFLAVORED WAXED FLOSS 55 YD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for REACH WAXED UNFLAVORED WAXED FLOSS 55 YD manufactured by Johnson And Johnson Consumer Inc..

Event Text Entries

[139719746] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085093
• MDR Report Key: 8444303
• Date Received: 2019-03-21
• Date of Report: 2019-03-20
• Date of Event: 2019-03-17
• Date Added to Maude: 2019-03-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: REACH WAXED UNFLAVORED WAXED FLOSS 55 YD
• Generic Name: FLOSS, DENTAL
• Product Code: JES
• Date Received: 2019-03-21
• Lot Number: 26918D
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON AND JOHNSON CONSUMER INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-21