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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITHKLINE POLIDENT HYPOALLERGENIC DENTURE ADHESIVE CREAM

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GLAXOSMITHKLINE POLIDENT HYPOALLERGENIC DENTURE ADHESIVE CREAM Back to Search Results
Event Date 01/28/2010
Event Type  Other  
Manufacturer Narrative

Polident hypoallergenic cream is marketed under the brand name super poligrip free in the us and is mfg in (b)(4). Neither the lot number nor the product was available. Polident maximum adherence is not marketed in the us. (b)(4).

 
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Brand NamePOLIDENT HYPOALLERGENIC
Type of DeviceDENTURE ADHESIVE CREAM
Manufacturer (Section D)
GLAXOSMITHKLINE
rtp NC
Manufacturer (Section G)
GLAXOSMITHKLINE, IRELAND
clocherane, youghal rd.
dungarvan
IRELAND
Manufacturer Contact
po box 13398
research triangle park , NC 27709
MDR Report Key1993352
Report Number9681138-2011-00032
Device Sequence Number1
Product CodeKOL
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/26/2011
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
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/05/2011 Patient Sequence Number: 1
Treatment
TRIATEC
KARDEGIC
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