SUPER 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 2004-04-23 for SUPER POLIGRIP * manufactured by Glaxosmithkline Consumer Healthcare Med Affairs, Us Prod Safety.

Event Text Entries

[310556] Consumer reported having experienced a loss of consciousness during an episode of severe diarrhea while using super poligrip dental adhesive. The consumer further reported that they have had 12 similar episodes of a brief loss of consciousness during bouts of severe diarrhea since they were younger. The consumer who had never discussed these episodes with their physician or sought medical attention for these events, declined to report specific details about their past espiodes. The consumer contacted the mfr to report their experience. A physician or other health care professional has not verified this report. In 2004, the consumer began the use of super poligrip daily. The following day the consumer experienced stomach cramps with loose stools that continued until 3 days later. One day ago the consumer took peptobismol to help relieve their symptoms of diarrhea but they reported that it had not helped. The consumer further reported that they had super poligrip in place for twenty four hours, because they had not rinsed their mouth or removed their dentures before sleep. On the morning of the following day, the consumer awoke from sleep with severe stomach cramps and several episodes of severe, watery, diarrhea that came in five-minute waves and lasted for about a half-hour. The consumer reported that they became lightheaded, had chills and had a loss of consciousness while on the toilet during their last wave of watery diarrhea. They reported that they awoke up about a minute on the floor next to the toilet and they could not recall how they got there. The consumer reported that they then began feeling very weak, vomited and then went to rest in bed. The consumer was alone during the event and they did not call for help from spouse who was in another part of the home.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2004-00004
• MDR Report Key: 522205
• Report Source: 04
• Date Received: 2004-04-23
• Date of Report: 2004-04-21
• Date of Event: 2004-02-27
• Date Mfgr Received: 2004-03-23
• Device Manufacturer Date: 2003-05-01
• Date Added to Maude: 2004-04-28
• 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 RD
• Manufacturer City: PARSIPPANY NJ 070543884
• Manufacturer Country: US
• Manufacturer Postal: 070543884
• Manufacturer Phone: 9738892494
• Manufacturer G1: GLAXOSMITHKLINE, IRELAND
• Manufacturer Street: YOUGHAL ROAD CLOHERANE
• Manufacturer City: DUNGARVIN
• Manufacturer Country: EI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPER POLIGRIP
• Generic Name: DENTURE ADHESIVE
• Product Code: KOP
• Date Received: 2004-04-23
• Model Number: *
• Catalog Number: *
• Lot Number: R03211
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 511334
• Manufacturer: GLAXOSMITHKLINE CONSUMER HEALTHCARE MED AFFAIRS, US PROD SAFETY
• Manufacturer Address: 1500 LITTLETON RD. PARSIPPANY NJ 070543884 US

Patients

Patient Number	Treatment	Outcome	Date
1	1	1. Other	2004-04-23