CVS DENTURE CLEANSER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-29 for CVS DENTURE CLEANSER manufactured by .

Event Text Entries

[21583221] I am writing this letter to inform you of a product that needs to be removed from the market. In 2007, i purchased a box of denture cleanser. My orthodontist instructed me to clean my retainer by soaking it in denture cleanser. Usually, i used one of the brand name effervescent tablets such as polident. However, on this day i bought the store brand instead. I soaked my retainer as i always do and it started to disintegrate. As a result, i had to go back to the orthodontist and have it replaced. I am sending you a sample of the tablet, so you can have it tested. I don't want the same incident to happen to another customer. I have been soaking my retainer for the past five years and this never happened when i used polident. I didn't realize the generic brands weren't safe. I have included a copy of the bar code and copy of my receipt. If you need to contact me to answer any questions, please feel free to give me a call. Thanks in advance for your immediate attention to this very important matter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5004322
• MDR Report Key: 939360
• Date Received: 2007-10-29
• Date of Report: 2007-10-07
• Date of Event: 2007-08-30
• Date Added to Maude: 2007-11-20
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CVS DENTURE CLEANSER
• Generic Name: NONE
• Product Code: JER
• Date Received: 2007-10-29
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 915114

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-10-29