GLAXO SMITH KLINE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-24 for GLAXO SMITH KLINE * manufactured by Glaxo Smithkline Dungarven.

Event Text Entries

[331489] Consumer had a reaction to poli-grip. The skin of their mouth suffered a chemical burn, and as a consequence, they now have "chelitis. " the doctor gave them "aphthous" to relieve the pain in their mouth. Consumer is a diabetic and because of the pain, they could not eat and their blood glucose went very low. Consumer used polygrip 1 and polygrip 2 with no problem. Consumer purchased poligrip 3 in june 2003. They used the tube for 4 days. It started burning their mouth and they purchased a second tube of poligrip 3. This tube they used for approx. 4 days. Later on, they realized both of these poli-grips were of the same code, although they were purchased in different stores.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW4003583
MDR Report Key	490421
Date Received	2003-09-24
Date of Report	2003-07-31
Date of Event	2003-06-09
Date Added to Maude	2003-10-23
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	GLAXO SMITH KLINE
Generic Name	POLI GRIP 3
Product Code	KOP
Date Received	2003-09-24
Model Number	*
Catalog Number	*
Lot Number	RO3103
ID Number	*
Device Availability	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	479155
Manufacturer	GLAXO SMITHKLINE DUNGARVEN
Manufacturer Address	* KNOCKBRACK DUNGARVAN EI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-09-24