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

Lot Number KB6M

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident denture adhesive cream.

Event Description

Abdominal pain [abdominal pain].Accidental swallowing [accidental device ingestion].Inappropriate dosing frequency [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a (b)(6) female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number kb6m, expiry date october 2019) for drug use for unknown indication.Concurrent medical conditions included gum atrophy.On an unknown date, the patient started polident denture adhesive cream at an unknown dose twice daily.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced abdominal pain (serious criteria hospitalization), accidental ingestion of drug, accidental overdose and drug use for unapproved schedule.The action taken with polident denture adhesive cream was unknown.On an unknown date, the outcome of the abdominal pain, accidental ingestion of drug, accidental overdose and drug use for unapproved schedule were unknown.It was unknown if the reporter considered the abdominal pain to be related to polident denture adhesive cream.Additional details, the consumer reported she used polident denture adhesive cream twice a day.She used once daily in the past.But since the gum atrophy happened due to ageing, the denture became loose so she need to use the product again for dinner (inappropriate dosing frequency.The label suggested consumer to use the product once a day.The intentionality was unknown).She suspected she had swallowed the cream and worried if it was harmful (accidental swallowing, unintentional).The consumer had used polident denture adhesive cream for over 10 years.She used the product twice daily for 2 years.She has experienced abdominal pain twice in a year (abdominal pain).In 2017, she was hospitalized.Her physician suspected it was bowel obstruction.But it was found out that she had no bowel obstruction after surgery.The intestine was not cut.The consumer suspected if the pain was due to swallowing the cream.She thought she had swallowed 10 tubes of cream.She had no other discomfort experienced.The consumer used the product for lower jaw complete denture only.When she used the product, she rinsed her denture first, removed excess water off the denture, applied the cream to her denture and then wore it.She applied 3 strips on her denture.She thought the product instruction only mentioned about the dosage for upper jaw denture but not lower jaw denture so she applied 3 strips on her denture (accidental overdose, unintentional).Follow up was received on 06 aug 2018, the consumer's family confirmed the batch number.This report is being resubmitted to capture corrections.The information was received on 03 aug 2018 and is as follows.The events accidental ingestion of drug and drug use for unapproved schedule were updated as accidental device ingestion and device used for unapproved schedule.The causality for accidental device ingestion and device used for unapproved schedule were updated to unknown.

Manufacturer Narrative

Argus case: (b)(4), polident denture adhesive cream.Device evaluation for complaint: (b)(4) (12-sep-2018): this is the tenth complaint of this nature for this batch, on review of the batch quantity the parts per million figures is low, therefore no further actions will be taken at this time.The analytical release data was reviewed by quality and all results were within specification requirements for this batch.Stability data confirms that the product remains within specification for the duration of the shelf life for this product.A notification review check was carried out on this batch which relates to manufacturing deviations, vendor investigations, change controls and laboratory investigations, there were no issues noted during the manufacture of this batch as per the defect of this complaint received.The complaint was found to be unsubstantiated.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 9-decade-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number: kb6m, expiry date october 2019) for drug use for unknown indication.Concurrent medical conditions included gum atrophy.On an unknown date, the patient started polident denture adhesive cream at an unknown dose twice daily.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced abdominal pain (serious criteria hospitalization), accidental ingestion of drug, accidental overdose and drug use for unapproved schedule.The action taken with polident denture adhesive cream was unknown.On an unknown date, the outcome of the abdominal pain, accidental ingestion of drug, accidental overdose and drug use for unapproved schedule were unknown.It was unknown if the reporter considered the abdominal pain to be related to polident denture adhesive cream.Additional details, the consumer reported she used polident denture adhesive cream twice a day.She used once daily in the past.But since the gum atrophy happened due to ageing, the denture became loose so she need to use the product again for dinner (inappropriate dosing frequency.The label suggested consumer to use the product once a day.The intentionality was unknown).She suspected she had swallowed the cream and worried if it was harmful (accidental swallowing, unintentional).The consumer had used polident denture adhesive cream for over 10 years.She used the product twice daily for 2 years.She has experienced abdominal pain twice in a year (abdominal pain).In 2017, she was hospitalized.Her physician suspected it was bowel obstruction.But it was found out that she had no bowel obstruction after surgery.The intestine was not cut.The consumer suspected if the pain was due to swallowing the cream.She thought she had swallowed 10 tubes of cream.She had no other discomfort experienced.The consumer used the product for lower jaw complete denture only.When she used the product, she rinsed her denture first, removed excess water off the denture, applied the cream to her denture and then wore it.She applied 3 strips on her denture.She thought the product instruction only mentioned about the dosage for upper jaw denture but not lower jaw denture so she applied 3 strips on her denture (accidental overdose, unintentional).Follow up was received on 06 aug 2018, the consumer's family confirmed the batch number.This report is being resubmitted to capture corrections.The information was received on 03 aug 2018 and is as follows.The events accidental ingestion of drug and drug use for unapproved schedule were updated as accidental device ingestion and device used for unapproved schedule.The causality for accidental device ingestion and device used for unapproved schedule were updated to unknown.Follow up information received from quality assurance department on 12 sep 2018: quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; knockbrack, dungarvan, waterford ; EI
• MDR Report Key: 7778092
• MDR Text Key: 116954316
• Report Number: 3003721894-2018-00282
• 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: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: KB6M
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 90 YR