MAUDE Adverse Event Report: REGENT LABS, INC. STAIN AWAY PLUS DENTURE CLEANER

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 03/07/2017

Event Type  Injury  

Event Description

I purchased stain away plus denture cleaner for the first time because i had never seen it before.I have an upper denture and a bottom partial.I soaked 15 minutes, as suggested because my partial had metal in it.When time was up i set the cup under running water while i washed my face and brushed my own teeth.I removed them from the cup and continued to rinse them.When i put them in my mouth i didn't like how they felt.So i took them out and brushed them with a toothbrush and tooth paste.Even though it is not usual i slept without my dentures that night.I just didn't feel comfortable.The next morning i awoke to a sore mouth.When i looked in the mirror my bottom lip was deep, dark red and swollen twice its size.There were small blisters all inside my lower lip and covered areas inside of my mouth, especially the root of my mouth.I can not eat or even drink anything except cold water.I am rinsing with salt water and soaking the dentures in baking soda and water in an effort to remove any leftover residue.I am in constant pain and discomfort.Is the product over-the-counter: yes.Frequency: other - as needed.How was it taken or used: other - soak dentures in.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.Why was the person using the product: this was just to clean my dentures.

• Brand Name: STAIN AWAY PLUS DENTURE CLEANER
• Type of Device: STAIN AWAY PLUS DENTURE CLEANER
• Manufacturer (Section D): REGENT LABS, INC.
• MDR Report Key: 6399033
• MDR Text Key: 69994541
• Report Number: MW5068399
• Device Sequence Number: 1
• Product Code: EFT
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: JANUVIA; LANTOS SOLOSTAR; NORCO; OTC MEDS: VITAMIN D; POTASSIUM; RX MEDS: ATENOLOL; TRAZODONE; TYLENOL; ZOLOFT
• Patient Outcome(s): Disability
• Patient Age: 81 YR
• Patient Weight: 51