CAVICIDE SPRAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for CAVICIDE SPRAY manufactured by Metrex Research.

Event Text Entries

[119208433] A (b)(6) dentist at (b)(6) medical center, (b)(6), used cavicide to clean my valplast partials and it caused pain, inflammation, chemical burns, blisters and ulcers. I reported this years ago and you did nothing, and they continue to clean dentures with cavicide, which is a violation of federal law because the label clearly states this product cannot be used inconsistent with the labeling and the label states it cannot be used on anything that touches intact mucous membrane, which lines the mouth. This continuation of violation of federal law is negligence per se and your knowledge of it and its continuation without your intervention is endorsing breaking the law. Cavicide is a registered and considered a medical device. Ref mfr# 1722021-2014-00010.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5079537
• MDR Report Key: 7842300
• Date Received: 2018-08-31
• Date of Report: 2018-08-29
• Date of Event: 2014-05-09
• Date Added to Maude: 2018-09-04
• 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: CAVICIDE SPRAY
• Generic Name: DISINFECTANT MEDICAL DEVICE
• Product Code: LRJ
• Date Received: 2018-08-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: METREX RESEARCH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-08-31