MAUDE Adverse Event Report: SMARTGUARD RX INC. SMARTGUARD PREMIUM CLEANER; CLEANSER, DENTURE, OVER THE COUNTER

Lot Number 024514M

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Cognitive Changes (2551); Chemical Exposure (2570)

Event Date 06/01/2022

Event Type  Injury  

Event Description

I started using a denture cleaner in (b)(6) of 2022 which contains a persulfate.I did not know this was potentially toxic.I used the product as instructed on dental retainers.It took two months for symptoms to begin showing.Pain throughout my body including severe stiffness which was unexplained and for no apparent reason at the time.It was also causing recurring problems with memory and brain fog.I had a battery of blood tests and a thermogram which showed irritation of my gums that of which i didn't feel but showed up on the report.Tests showed no body inflammation.X-rays showed no signs of arthritis.A nerve conduction study showed no signs of issues involving tissue or muscular function.I also took a heavy metal and toxicity work up.Those results haven't been produced yet but i'm still waiting.After reviewing all of the evidence, i decided to do some research on the ingredients of the denture cleaner as that was the only new product i came in contact during this time.When a week of stopping the usage of this product, the pain has diminished greatly although not completely gone.I suspect the persulfate is the culprit.Reason for use: clean dental retainers.

• Brand Name: SMARTGUARD PREMIUM CLEANER
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): SMARTGUARD RX INC.
• MDR Report Key: 15282681
• MDR Text Key: 298607032
• Report Number: MW5111664
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• 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: 08/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 024514M
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White