MAUDE Adverse Event Report: CVS HEALTH OVERNIGHT WHITENING DENTURE CLEANSER; CLEANSER, DENTURE, OVER THE COUNTER

Lot Number 8178060

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Burning Sensation (2146); Reaction (2414); Numbness (2415); Choking (2464); Ambulation Difficulties (2544)

Event Date 06/08/2020

Event Type  Injury  

Event Description

(b)(6) brand denture cleanser used to soak and clean plastic teeth retainers.Before bed rinsed, put in mouth, within half hour, choking on saliva, throat closing, burning throat, tongue, lips swollen throat.Numb hands, feet.Painful to walk and put pressure on feet.Shortness of breath, continued wheeziness.Became asthmatic; anaphylactic reaction.I have been to the doctor several times, given an inhaler, asked if i was asthmatic.(b)(6) pharmacy inc.

• Brand Name: CVS HEALTH OVERNIGHT WHITENING DENTURE CLEANSER
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• MDR Report Key: 10142991
• MDR Text Key: 194992269
• Report Number: MW5094951
• Device Sequence Number: 1
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/20/2021
• Device Lot Number: 8178060
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 52 YR
• Patient Weight: 86