MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD. POLIDENT DENTURE ADHESIVE CREAM

Device Problem Melted (1385)

Patient Problems Renal Failure (2041); Jaundice (2187); Toxicity (2333); Dysuria (2684); Foreign Body In Patient (2687)

Event Type  Other  

Manufacturer Narrative

Fu made with the consumer on 15/jul/2015.He used to use the product once a day, but as the weather got warmer, he applied the product twice a day, squeezing small amount of the product.The consumer discontinued the product at the time of follow-up.He had never experienced renal disease before.He was hospitalized on (b)(6) 2015, and admitted for 17 days.At first, he experienced urination difficulty, and visited a hospital and got a blood test.Jaundice was concurrently developed.Liver enzyme level was normal, though.So thus he was hospitalized.First diagnosis result was acute renal failure due to drug intoxication.As the consumer told the doctor the truth that he was using polident denture adhesive cream and his dietary habits and etc, physician diagnosed that the symptom seemed to be related to polident denture adhesive cream.The symptoms were recovering.

Event Description

Acute renal failure.Difficulty in urination.Jaundice.Drug intoxication.Case description: this case was reported by a consumer via call center representative and described the occurrence of acute renal failure in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.Concurrent medical conditions included acute renal failure.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced acute renal failure (serious criteria hospitalization and gsk medically significant), urination difficulty, jaundice and drug intoxication.On an unknown date, the outcome of the acute renal failure, urination difficulty, jaundice and drug intoxication were recovering/resolving.The reporter considered the acute renal failure, urination difficulty, jaundice and drug intoxication to be probably related to polident denture adhesive cream.Additional details: concurrent drug: no.Concurrent disease: acute renal failure.Direct contact to hcp: disagree.A male consumer born in (b)(6) had used polident denture adhesive cream for adhesive denture since one year ago, and at the time of initial reporting, he did not discontinue the product.He applied the product twice a day on upper and lower dentures.The consumer said since one year ago, the product was melted and swallowed whenever he used polident denture adhesive cream.There had been no other adverse event while using the product.But on (b)(6) 2015, as he had difficulty in urination, he visited a hospital and was hospitalized for around 16 days.On (b)(6) 2015, via hospital, he heard the symptom was acute renal failure.He was taken a biopsy to figure out the cause of disease.Polident denture adhesive cream was one option of the causes during cause analysis.He visited the hospital at this initial reporting date, and according to the consumer, the physician said recovery speed of the disease was slow, and the reason of slow recovery was polident denture adhesive cream and the physician also regarded polident denture adhesive cream as the cause of disease.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD.; dungarvan, waterford ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4995093
• MDR Text Key: 23393513
• Report Number: 3003721894-2015-00001
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 07/14/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other