POLIDENT DENTURE ADHESIVE CREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-06-23 for POLIDENT DENTURE ADHESIVE CREAM manufactured by Glaxosmithkline Dungarvan Ltd.

Event Text Entries

[5809858] Collapsed [collapse vascular], (b)(6), ingestion of product [accidental device ingestion], decreased appetite [decreased appetite], malnutrition [malnutrition], anemia [anemia], overdose [overdose], chewing ability worsened [chewing difficulty], eating discomfort [eating disorder], weak [weakness], weird sticky feeling [product adhesion issue], product taste abnormal [product taste abnormal]. Case description: this case was reported by a consumer and described the occurrence of collapse in a female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number v13463, expiry date november 2016) for denture wearer. Concurrent medical conditions included hypertension. Additional patient notes included had no medical history related to lung and (b)(6). Concomitant products included medication unknown (hypertension drug (unknown)). Fda use only in 2013, the patient started polident denture adhesive cream. On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced collapse (serious criteria hospitalization and gsk medically significant), (b)(6) (serious criteria gsk medically significant), possible ingestion of device (serious criteria gsk medically significant), decreased appetite, malnutrition, anemia, overdose, chewing ability worsened, eating disorder, weak, product adhesion issue and product taste abnormal. The patient was treated with drugs for treatment of (b)(6), drugs for treatment of (b)(6) and antianaemic medication nos. On an unknown date, the outcome of the collapse, (b)(6), possible ingestion of device, decreased appetite, malnutrition, anemia, overdose, chewing ability worsened, eating disorder, weak, product adhesion issue and product taste abnormal were unknown. It was unknown if the reporter considered the collapse, (b)(6), possible ingestion of device, decreased appetite, malnutrition, anemia, overdose, chewing ability worsened, eating disorder, weak, product adhesion issue and product taste abnormal to be related to polident denture adhesive cream. Additional information: reporter : consumer's foster daughter a female consumer born in (b)(6) had used polident denture adhesive cream for adhesive denture since about 1 year ago. She kept using the product at the time of reporting. Usually she used the product once daily, every morning, but sometimes used it twice daily to take a denture. She spent about 1 tube of the product during one week. From about 1 year ago, because of the weird sticky feeling and flavor such as the product was swallowed inside her neck, she developed decreased appetite and ate less food. About 10 days ago from this reporting, she collapsed and was diagnosed (b)(6) and anemia by malnutrition. When she attached the denture with wire, she did not have food intake disorder, but after using polident denture adhesive cream, she had difficulty in taking food. (b)(6) and anemia were being treated. She did not get dental treatment or diagnostic test. She was hospitalized from (b)(6) 2014 by being collapsed. She had no medical history related to lung and (b)(6). Decreased appetite did not occur at product first used days. Instead, as chewing ability got worse by denture usage and the flavor of the product made her discomfort to eat, she gradually became weak. At the time of following, the consumer discontinued the medication for (b)(6) and anemia because of nausea, so took only medication for hypertension. The reporter did not consult with the internist about polident denture adhesive cream and did not go to see a dentist. At the first reporting ((b)(6) 2014), the customer center tried to inform correct guidance for product usage because of overdose, but the reporter rejected it and had asked to receive a compensation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2014-00051
MDR Report Key4864982
Report Source01,04
Date Received2015-06-23
Date Mfgr Received2014-11-03
Date Added to Maude2015-06-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer StreetPO BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Manufacturer G1GSK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLIDENT DENTURE ADHESIVE CREAM
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-06-23
Lot NumberV13463
Device Expiration Date2016-11-01
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD
Manufacturer AddressDUNGARVAN EI


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-23

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