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MAUDE Adverse Event Report

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GLAXOSMITHKLINE SUPER POLIGRIP ORIGINAL DENTURE CREAM DENTURE ADHESIVE CREAM   Back to Search Results
Lot Number R06371A
Event Type  Other   Patient Outcome  Other;
Event Description

This case was reported by a consumer and described the occurrence of worsening of liver cancer in a 78-year-old male patient who received poligrip (super poligrip original denture adhesive cream) over a period of two and one half months for loose dentures. A physician or other health care professional has not verified this report. The patient's past medical history included skin melanoma. Concurrent medical conditions included codeine allergy. Concurrent medications were unknown (unspecified medications). Approximately two and one half months prior to the report. In 2007, the patient started poligrip (dental). At an unknown time after starting poligrip, the patient experienced worsening of liver cancer. The patient reported that he was recently advised by his doctor that he had developed more nodules on his liver and the cancerous nodules were appearing faster then they were before. This case was assessed as medically serious by gsk. Treatment with poligrip was continued. At the time of reporting, the event was unresolved. Manufacturer's comment: the manufacturer report number for this case is 9681138-2007-00003. Super poligrip is manufactured in internationally. The lot number for this product is available, however, the product is not available. No corrective actions have been required based on this report.

 
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Brand NameSUPER POLIGRIP ORIGINAL DENTURE CREAM
Type of DeviceDENTURE ADHESIVE CREAM
Manufacturer (Section D)
GLAXOSMITHKLINE
rtp NC
Manufacturer (Section G)
GLAXOSMITHKLINE
youghal road
dungarvan
IRELAND
Manufacturer Contact
p.o. box 13398
research triangle park , NC 27709
(888) 825 -5249
Device Event Key832488
MDR Report Key842834
Event Key805670
Report Number9681138-2007-00003
Device Sequence Number1
Product CodeKOO
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 04/25/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device LOT NumberR06371A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Device Age na
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/17/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 04/25/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
1,UNKNOWN
 
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