MAUDE Adverse Event Report: GLAXOSMITHKLINE CONSUMER HEALTHCARE, LP POLIDENT ANTIBACTERIAL DENTURE CLEANER; CLEANSER, DENTURE, OVER THE COUNTER

Lot Number MA031814E

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Date 08/11/2018

Event Type  Injury  

Event Description

Continued and worsening allergic reaction to polident.I used it to clean retainers as was suggested by dentist.I've been getting swollen and sore lips in reaction to it.Is the product over-the-counter: yes; did the product stop after the person reduced the dose or stopped taking or using the product: yes; did the product return if the person started taking or using the product again: yes.Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018.

• Brand Name: POLIDENT ANTIBACTERIAL DENTURE CLEANER
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): GLAXOSMITHKLINE CONSUMER HEALTHCARE, LP
• MDR Report Key: 7784497
• MDR Text Key: 117309062
• Report Number: MW5079154
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: MA031814E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 54