MAUDE Adverse Event Report: MEDTECH PRODUCTS, INC. EFFERDENT ESSENTIAL CLEAN 5-IN-1 CLEANSING SYSTEM TABLETS; CLEANSER, DENTURE, OVER THE COUNTER

Model Number 82R801

Device Problems Labelling, Instructions for Use or Training Problem (1318); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 06/01/2021

Event Type  No Answer Provided  

Event Description

Product: efferdent essential clean 5-in-1 cleansing system tablets- on 07/15/2021, a complainant called to report she is concerned that the ingredient list is not on the product container.She also stated she did not see the ingredient list on the company website.Complainant later also reported she used the product on a monday and noticed her lips became inflamed.A few days later, she then tested the product on her arm and noticed welts within six hours.Complainant is unsure of the exact dates.Complainant was seen at (b)(6) in (b)(6) for her inflamed lips.Complainant had not yet tested the product on her arm at that time.Complainant does not have the outer product box as only a product blister pack was given to her by a friend.However, she provided the lot number as 1483201587.Complainant contacted the firm with her concern.Complainant gave permission to share her contact information.Complainant provided a photo of the back label and stated that her friend has not experienced a problem with this product.This product is classified as a medical/dental device per: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.Cfm?fr=872.3520.Injury/illness: inflamed lips and welts when applied to forearm.Mr.(b)(6), prestige brands, response continued from this cc, pg 2, initial disposition: on 07/23/2021, mr.(b)(6), who provided the corp hq emailed the following statement: "i was informed you had contacted us regarding a consumer who used our efferdent complete clean original tablets, with a specific inquiry into the ingredients list.Although not required by regulation, i wanted to reach out to share with you more of the details regarding this product and provide you the qualitative ingredient listing.The inactive ingredients for our efferdent complete clean original tablets are as follows - potassium monopersulfate, anhydrous citric acid, sodium bicarbonate, sodium carbonate, sodium carbonate peroxide, sorbitol, peg 8000, tetramethylethylenediamine, flavor, sodium lauryl sulfoacetate, magnesium stearate, peg 8, corn syrup, sodium benzoate, fd&c blue #2, peppermint oil.Additionally, the directions state that the dentures should be rinsed.We will reach out to the consumer to ensure they have this information as well." case number (b)(4).Symptom: local swelling, rash; system affected: blood or lymphatic, skin; onset time: immediate, 6 hours; duration: 1.5 weeks.Remarks: lips became inflamed, welts when applied to forearm.Qty: 102 tablets box.Purchase date: "in 05 or 06/2021." amount consumed/used: 2.

• Brand Name: EFFERDENT ESSENTIAL CLEAN 5-IN-1 CLEANSING SYSTEM TABLETS
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): MEDTECH PRODUCTS, INC.
• MDR Report Key: 12576287
• MDR Text Key: 275518939
• Report Number: MW5104373
• Device Sequence Number: 1
• Product Code: EFT
• UDI-Device Identifier: 00814832015879
• UDI-Public: 814832015879
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 82R801
• Device Catalogue Number: 76E-FT
• Device Lot Number: 148320158
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1