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

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The cream got collected at the back of her throat and made her feel sick [foreign body in throat].Makes me feel sick.[feeling unwell].I am having to apply it 3 or 4 times a day [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a female patient who received double salt dental adhesive cream (poligrip 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 poligrip denture adhesive cream.On an unknown date, an unknown time after starting poligrip denture adhesive cream, the patient experienced foreign body in throat (serious criteria gsk medically significant), feeling unwell, device used for unapproved schedule and product complaint.The action taken with poligrip denture adhesive cream was unknown.On an unknown date, the outcome of the foreign body in throat, feeling unwell, device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, feeling unwell and device used for unapproved schedule to be related to poligrip 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: (initial, fu 1 & 2 was processed together) the consumer reported that she used the product to fix her dentures.Unfortunately it did not last very long.She had to apply it 3 or 4 times a day, she had tried other brands and they were all the same.She asked for any suggestions.The cream got collected at the back of her throat and made her feel sick.Follow up information received on 20 nov 2020: the product quality complaint number was reported as (b)(4).Follow up information was received on 25 nov 2020 from quality assurance (qa) department regarding complaint ((b)(4)) (complaint reference).Summary and conclusion 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 was 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.Complaint conclusion: unsubstantiated.Quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: POLIGRIP 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,; 8888255249
• MDR Report Key: 10941156
• MDR Text Key: 221480979
• Report Number: 3003721894-2020-00341
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2020

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/03/2020
• 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
• Patient Outcome(s): Other