MAUDE Adverse Event Report: GSK CONSUMER HEALTH INC. SUPER POLYGRIP WITHOUT ZINC; CLEANSER, DENTURE, OVER THE COUNTER

Lot Number 2

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 06/15/2021

Event Type  No Answer Provided  

Event Description

Used polygrip without zinc and had angioedema within 3hrs of wearing partial dental appliance.Swelling of lips and face for close to 3 days.I am allergic to many medicines, foods and other inhalants, and latex.Have had all allergy testing for past 25 years.Allergic to most antibiotics and also latex and foods.Needed to take medrol pack for 3 days to resolve.Not a zinc problem cause used zinc free.

• Brand Name: SUPER POLYGRIP WITHOUT ZINC
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): GSK CONSUMER HEALTH INC.
• MDR Report Key: 12238638
• MDR Text Key: 264064788
• Report Number: MW5102792
• 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: 07/24/2021

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 Expiration Date: 06/15/2021
• Device Lot Number: 2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 55