SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-08-08 for SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM * manufactured by Glaxosmithkline.

Event Text Entries

[18328216] This case was reported by a consumer and described the occurrence of allergic reaction in a consumer who used super poligrip free denture adhesive cream (triple gantrez salt and sodium carboxymethylcellulose. ). A physician or other health care professional has not verified this report. Concurrent medical conditions include allergy to bees, allergy to super poligrip, (unspecified formulation, date and reaction), and allergy to fixodent. The consumer carries an epi-pen for their bee allergy. Concurrent medications include diazepam, lorcet, ranitidine hydrochloride (zantac) and prempro. A few years ago, the consumer started using super poligrip free denture adhesive cream (double gantrez salt and sodium carboxymethylcellulose) uneventfully. In 2003 the consumer began using the super poligrip free denture adhesive cream, (triple gantrez salt and sodium corboxymethylcellulose). After their first application of the triple salt formulation the consumer experienced an allergic reaction described as throat swelling and difficulty breathing. The consumer took diphenhydramine hydrochloride and removed their dentures at home but did not use their epi-pen. The consumer stated they knew it was an allergic reaction because they experienced a similar reaction to fixodent in the past. It is unk what type of reaction the consumer had to super poligrip in the past. Pt drove themselves to the emergency room. In the emergency rrom they received a shot which they believed was adrenaline. The events resolved quickly and consumer was released from the emergency room 20 minutes later. The consumer has not restarted the super poligrip free denture adhesive cream (triple gantrez salt and sodium carboxymethylcellulose. Manufacturer's comment: this case had been assessed as medically serious by the safety physician.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2003-00003
• MDR Report Key: 477703
• Report Source: 04
• Date Received: 2003-08-08
• Date of Report: 2003-08-06
• Date of Event: 2003-06-01
• Date Mfgr Received: 2003-07-25
• Device Manufacturer Date: 2003-03-01
• Date Added to Maude: 2003-08-15
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 1500 LITTLETON RD
• Manufacturer City: PARSIPPANY NJ 070543884
• Manufacturer Country: US
• Manufacturer Postal: 070543884
• Manufacturer Phone: 9738892494
• Manufacturer G1: GLAXOSMITHKLINE, IRELAND
• Manufacturer Street: YOUGHAL ROAD DUNGARVIN
• Manufacturer City: CLOCHERANE
• Manufacturer Country: EI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM
• Generic Name: DENTURE ADHESIVE
• Product Code: KOP
• Date Received: 2003-08-08
• Model Number: *
• Catalog Number: *
• Lot Number: R03102
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 466509
• Manufacturer: GLAXOSMITHKLINE
• Manufacturer Address: 1500 LITTLETON RD PARSIPPANY NJ 070543884 US

Patients

Patient Number	Treatment	Outcome	Date
1	2	1. Other	2003-08-08