MAUDE Adverse Event Report: MEDTECH PRODUCTS, INC. EFFERDENT; CLEANSER, DENTURE, OVER THE COUNTER

Lot Number 0162626

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

I was given polident with my new dentures in (b)(6).I started having trouble breathing around the same time i started using this product.I am deathly allergic to penicillin but was given this product by the dentist that made the dentures, no warnings of any kind.My breathing continued to get worse and on 2 occasions i required treatment in the e.R.No one was able to explain the sudden onset of breathing problems.When i ran out of the samples, i was given i bought efferdent because it was cheaper.I got horrible sores all inside of my mouth and was unable to wear my dentures for several days.While my dentures where out my breathing got better.I always rinse my dentures well with running water, so i made no connection.I was researching what could have caused the mouth sores and found several warnings about the products.I am currently using only baking soda on my dentures and my respiratory problems have been relieved.I could have died please take some kind of action to let people know you can have these kind of allergic reactions to these products.Healthcare providers should know as well.I have had a gazillion test and have been treated twice in the e.R.I will release any info you need.Product type: over the counter.Strength: effervescent.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes.Quantity: 6 tablet(s).How was it taken or used? dentures soaked.Give best estimate of duration? 1 month.Why was the person using the product? clean dentures.Quantity: 20 tablet(s).Date the person first started taking or using the product: (b)(6) 2021.Date the person stopped taking or using the product: (b)(6) 2021.

• Brand Name: EFFERDENT
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): MEDTECH PRODUCTS, INC.
• MDR Report Key: 11595263
• MDR Text Key: 243560320
• Report Number: MW5100407
• Device Sequence Number: 2
• Product Code: EFT
• Combination Product (y/n): Y
• 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: 03/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 0162626
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 86