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

Device Problem Product Quality Problem (1506)

Patient Problem Diarrhea (1811)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Swallow it [accidental device ingestion].Diarrhea [diarrhea].Case description: this case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for product used for unknown indication.This case was associated with a product complaint.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 accidental device ingestion (serious criteria gsk medically significant), diarrhea and product complaint.On an unknown date, the outcome of the accidental device ingestion, diarrhea and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and diarrhea to be related to polident denture adhesive cream.Additional details, action taken of polident denture adhesive cream was unknown.The consumer had been using the product for a week.The cream melts down while using it and the consumer gets swallow it.He had been having diarrhea since he started using the cream.It doesn't get better with the medicine for diarrhea.He would see a doctor.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for product used for unknown indication.This case was associated with a product complaint.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 accidental device ingestion (serious criteria gsk medically significant), diarrhea and product complaint.On an unknown date, the outcome of the accidental device ingestion, diarrhea and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and diarrhea to be related to polident denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, action taken of polident denture adhesive cream was unknown.The consumer had been using the product for a week.The cream melts down while using it and the consumer gets swallow it.He had been having diarrhea since he started using the cream.It doesn't get better with the medicine for diarrhea.He would see a doctor.Follow up information was received on 13 may 2020 from quality assurance (qa) department regarding complaint ((b)(4)) (complaint reference) for unknown lot number.No sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.Quality assurance analysis revealed the complaint to be inconclusive.Case corrected as per information received on 13 may 2020.In device medwatch information additional information was ticked.Concomitant product included no therapy.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 10086612
• MDR Text Key: 195289643
• Report Number: 3003721894-2020-00118
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other