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

Device Problem Product Quality Problem (1506)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

Adhesive cream has disappeared, it seems like all of it have dissolved and have been swallowed [accidental device ingestion].S/he experienced stomachache [stomach pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident free denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started polident free denture adhesive cream.On an unknown date, an unknown time after starting polident free denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), stomach pain and product complaint.The action taken with polident free denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown and the outcome of the stomach pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion and stomach pain to be related to polident free 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: adverse event information was received from consumer via call center representative (phone) on (b)(6) 2022.The consumer stated, "using polident adhesive cream natural scent free product to attach the dentures.When s/he removed the dentures, based on the fact that the adhesive cream has disappeared, it seems like all of it have dissolved and have been swallowed, and s/he experienced stomachache.It may be enteritis or something and despite taking a 7-day course of medication (for the condition, the condition) is not improving".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident free denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started polident free denture adhesive cream.On an unknown date, an unknown time after starting polident free denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), stomach pain and product complaint.The action taken with polident free denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown and the outcome of the stomach pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion and stomach pain to be related to polident free 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: adverse event information was received from consumer via call center representative (phone) on (b)(6) 2022.The consumer stated, "using polident adhesive cream natural scent free product to attach the dentures.When s/he removed the dentures, based on the fact that the adhesive cream has disappeared, it seems like all of it have dissolved and have been swallowed, and s/he experienced stomachache.It may be enteritis or something and despite taking a 7-day course of medication (for the condition, the condition) is not improving".Follow up information was received on 17jan2022 from quality assurance (qa) department regarding complaint (b)(4) (case number) and pqc (b)(4) (pqc number) for unknown lot number and for unknown expiry date.Investigation evaluation: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a ]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Due to the adverse event and related hsi, could i kindly request that further information is requested from the complainant.Complaint conclusion: unsubstantiated.

• Brand Name: POLIDENT FREE DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 13282607
• MDR Text Key: 289064552
• Report Number: 3003721894-2022-00007
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Sex: Male