POLIGRIP *

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 2004-03-30 for POLIGRIP * manufactured by Glaxosmithkline Consumer Healthcare, Medical Affairs, Us Product Safety.

Event Text Entries

[334243] This case was reported by a consumer and described the occurrence of increased seizure activity in a patient who used poligrip (super poligrip extra care with poliseal). The consumer initially called to ask if there was any latex in poligrip and was informed that there was none. A physician or other health care professional has not verified this report. The consumer is a new denture wearer since september 2003 with a history of seizures since february 2002, secondary to neurocardiogenic syncope, and changed from an unknown seizure medication to lamictal in october. Consumer began using super poligrip extra care with poliseal either in early december 2003 (the consumer had been using another denture adhesive product and could not recall the exact start date of the poligrip) and experienced 11 seizures in january 2004. During the time of use (2003 to 2004), consumer only used poligrip sporadically as consumer complained that their dentures were painful and did not wear them frequently and for a few hours at a time. The consumer reported that prior to their use of super poligrip extra care with poliseal, consumer believes that their seizures were controlled with lamictal and their previous seizure, prior to the frequent seizures expereinced in january, had been in 2003. Prior to starting lamictal, the consumer could not specify how frequent their seizures were previously, nor could consumer specify what seizure medication they had been on in the past. The consumer also had experienced swelling of their gums, face and glands (the consumer could not provide an exact date, but believes these symptoms occurred prior to their use of super poligrip extra care with poliseal).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2004-00002
• MDR Report Key: 519268
• Report Source: 04
• Date Received: 2004-03-30
• Date of Report: 2004-03-17
• Date of Event: 2003-11-01
• Date Mfgr Received: 2004-02-17
• Device Manufacturer Date: 2003-05-01
• Date Added to Maude: 2004-04-07
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 1500 LITTLETON ROAD
• Manufacturer City: PARSIPPANY NJ 070543884
• Manufacturer Country: US
• Manufacturer Postal: 070543884
• Manufacturer Phone: 9738892494
• Manufacturer G1: GLAXOSMITHKLINE, IRELAND
• Manufacturer Street: CLOHE RANE YOUGHAL ROAD
• Manufacturer City: DUNGARVIN
• Manufacturer Country: EI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: POLIGRIP
• Generic Name: DENTURE ADHESIVE
• Product Code: KOP
• Date Received: 2004-03-30
• Model Number: *
• Catalog Number: *
• Lot Number: XO3214
• 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: 508327
• Manufacturer: GLAXOSMITHKLINE CONSUMER HEALTHCARE, MEDICAL AFFAIRS, US PRODUCT SAFETY
• Manufacturer Address: 1500 LITTETON ROAD PARSIPPANY NJ 070543884 US

Patients

Patient Number	Treatment	Outcome	Date
1	3	1. Other	2004-03-30