MAUDE Adverse Event Report: TOWER LABORATORIES LTD. RETAINER BRITE; OVER-THE-COUNTER DENTURE CLEANSER TABLETS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Patient's daughter reported the patient used the over-the-counter denture cleanser product to clean his sleep apnea device.She stated he had a severe allergic reaction which resulted in him spending 3 days in the hospital.She indicated he found out he was allergic to the potassium persulfate ingredient in the product.She mentioned he does not have a sulfa allergy and that he followed the directions on the box.This product does contain a persulfate allergy warning on the box.

• Brand Name: RETAINER BRITE
• Type of Device: OVER-THE-COUNTER DENTURE CLEANSER TABLETS
• Manufacturer (Section D): TOWER LABORATORIES LTD.; 8 industrial park road; centerbrook CT 06409
• Manufacturer (Section G): TOWER LABORATORIES LTD.; 7 heritage park road; clinton CT 06413
• Manufacturer Contact: crystal fisher ; 8 industrial park road; centerbrook, CT 06409 ; 8607672127
• MDR Report Key: 15490999
• MDR Text Key: 300646663
• Report Number: 1219540-2022-00001
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male