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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITHKLINEPOLIDENT HYPOALLERGENICDENTURE ADHESIVE CREAM

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GLAXOSMITHKLINE POLIDENT HYPOALLERGENIC DENTURE ADHESIVE CREAM   Back to Search Results
Event Date 01/28/2010
Event Type  Other   Patient Outcome  Hospitalization
Event Description

This case was reported by a consumer and described the occurrence of tingling hands and feet in a (b)(6) male pt who used polident maximum adherence denture adhesive cream as a denture adhesive. A physician or other health care professional has not verified this report. Concurrent medical conditions included heart disorder. Concurrent medications included lysine aspirin (kardegic) and ramipril (triatec). On an unk date, in 1985, the pt began using polident maximum adherence denture adhesive cream twice per day for 25 yrs. An unk time later, the pt experienced tingling hands and feet, pain in arms and legs, unbalance, hand and feet numbness, weakness and low leukocytes rate. On (b)(6) 2010, the pt went to the hosp and had a medical exam (the pt waited 7 hrs at the hosp) with a neurologist. The pt was not hospitalized. Blood test was done and showed low rate of leucocytes. On (b)(6) 2010, blood testing (zinc rate in blood) was performed. The pt would have a medical exam with the neurologist on (b)(6) 2010 and with a cardiologist on (b)(6) 2010. Use of polident maximum adherence was discontinued permanently in (b)(6) 2010 and he began using polident hypoallergenic nic ((b)(4)). At the time of reporting, the events were unresolved. F/u info received on (b)(6) 2010, from a physician: it was reported that the pt was using polident in large quantities. The pt was also reported to have experienced muscle weakness (previously reported as weakness), anemia and paresthesia. This case was assessed as medically serious by gsk. At the time of reporting, the events were unresolved. F/u received (b)(6) 2010, from a physician: the pt used the product until (b)(6) 2010. The physician confirmed the previously reported events. The events started on (b)(6) 2010. The physician considered the events to be probably related to polident intake. On (b)(6) 2010, lab data showed the following results: zinc 37. 8 umol/l (normal range 11 to 24); creatinine 55 umol/l (normal range 62 to 106); sodium 133 mmol/l (normal rate 135 to 145); alcaline rate (stock) 21 mmol/l (normal rate 23 to 29); calcic osmolarity 266 mosm/l (normal rate 280 to 320); alat 60 u/l (normal 5 to 50); myoglobine 17 ug/l (normal range 17 to 106); leucocytes 3. 29 g/l (normal rate 4 to 10); red cells 3. 85 t/l (normal rate 4 to 5. 5); t. C. M. H 32. 70 pg (normal rate 27 to 32); platelets 6. 30 fl (normal range 70 to 10); polynuclear cells (absolute value) 1. 28 g/l (normal range 2. 50 to 7. 50). No further info was provided. F/u info received on (b)(4) 2011: the pt details updated ((b)(6)). Co-suspect product now included polident hypoallergenic. The pt's wife reported that his health was not getting better and he was hospitalized several times. The pt still experienced pain which was not relieved by the medicines he was taking, weakness in the arms and legs, he was not able to stand a long time and get tired quickly with a single effort. During his hospitalization, various exams were performed: blood tests, scanner, mri, x-ray, bone marrow and lumbar punctures, nerves and muscles biopsy. In (b)(6) 2010, nerves and muscles biopsy concluded that the nerves were very affected. Since this date, the pt was treated and hospitalized in the neurology unit.

 
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 F)
GLAXOSMITHKLINE
rtp NC
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
Device Event Key2042180
MDR Report Key1993352
Event Key1890347
Report Number9681138-2011-00032
Device Sequence Number1
Product CodeKOL
Report Source Manufacturer
Source Type 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
Was The Report Sent To Manufacturer? 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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

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