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

Device Problem Product Quality Problem (1506)

Patient Problems No Code Available (3191); Constipation (3274)

Event Type  malfunction  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Swallowed product [accidental device ingestion], constipation [constipation], stools became hard [stools hard], couldn't pee [urination difficulty].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6)-year-old male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.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), constipation, stools hard, urination difficulty and product complaint.Polident denture adhesive cream was discontinued (dechallenge was positive).On an unknown date, the outcome of the accidental device ingestion, constipation, urination difficulty and product complaint were unknown and the outcome of the stools hard was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion, constipation, stools hard and urination difficulty to be related to polident denture adhesive cream.Additional details: polident denture adhesive cream was used to attach the denture.The reporter could not eat meals without using it.The cream remained when removing the denture after having a meal, the remainders of the cream in the mouth did not came out easily even if he used tooth brush to remove it.The remainders were mixed saliva in the mouth and became very sticky.The consumer either spit or swallowed it.He was not sure if that worsened his constipation, he had to go to an emergency room.He was not able to empty his bowel, had to go to the emergency room twice.He used enema in the emergency room, it was not helping.He could touch something stone-like when he put his fingers into anus.He thought stools became hard because of the adhesive cream.He could not pass the stool even if he tried very hard.He could not pee and going to the emergency room did not help.It was asked it there was a medication to dissolve the cream or what else he can try.He stopped using it and he was able to pass stools.

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 88-year-old male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.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), constipation, stools hard, urination difficulty and product complaint.Polident denture adhesive cream was discontinued (dechallenge was positive).On an unknown date, the outcome of the accidental device ingestion, constipation, urination difficulty and product complaint were unknown and the outcome of the stools hard was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion, constipation, stools hard and urination difficulty 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: polident denture adhesive cream was used to attach the denture.The reporter could not eat meals without using it.The cream remained when removing the denture after having a meal, the remainders of the cream in the mouth did not came out easily even if he used tooth brush to remove it.The remainders were mixed saliva in the mouth and became very sticky.The consumer either spit or swallowed it.He was not sure if that worsened his constipation, he had to go to an emergency room.He was not able to empty his bowel, had to go to the emergency room twice.He used enema in the emergency room, it was not helping.He could touch something stone-like when he put his fingers into anus.He thought stools became hard because of the adhesive cream.He could not pass the stool even if he tried very hard.He could not pee and going to the emergency room did not help.It was asked it there was a medication to dissolve the cream or what else he can try.He stopped using it and he was able to pass stools.Follow up information was received from quality assurance department on 28 nov 2019.Qa analysis revealed the complaint to be unsubstantiated.

Manufacturer Narrative

Received on 28-nov-2019: 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.Argus case: (b)(4).

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford; waterford, ; EI
• MDR Report Key: 9329048
• MDR Text Key: 184731787
• Report Number: 3003721894-2019-00334
• 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: 10/31/2019

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
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR