MAUDE Adverse Event Report: GLAXOSMITHKLINE POLIDENT OVERNIGHT WHITENING TABLET; DENTURE CLEANSER

Lot Number MF141413B

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414); Numbness (2415)

Event Date 09/09/2014

Event Type  Injury  

Event Description

Purchased on ((b)(6) 2014) a new 84 tablet box of polident antibacterial denture cleanser, overnight whitening.Stamp on top carton (b)(4).On (b)(6) 2014 placed one tablet and partial in denture soak case with water.Next morning i removed partial and rinsed before placing in mouth.Bad taste, immediately removed partial and rinsed mouth with clean water several times.Upper lip swelled and numb fuzzy feeling lip.Rinsed and soaked partial in fresh water before placing in mouth again.First time i have used polident.Used efferent for years no problem.Tried to contact polident manufacturer; put on hold over 10 minutes.I do not take any medications.Dose or amount: one tablet.Frequency: once daily.Route: denture cleaner.Date of use: (b)(6) 2014 - (b)(6) 2014.Diagnosis or reasons for use: clean denture partial.Event abated after use stopped or dose reduced: yes.

• Brand Name: POLIDENT OVERNIGHT WHITENING TABLET
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE
• MDR Report Key: 4093169
• MDR Text Key: 17693354
• Report Number: MW5038186
• Device Sequence Number: 1
• Product Code: EFT
• 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: 09/09/2014

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: Other
• Device Lot Number: MF141413B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Weight: 82