MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); DENTURE ADHESIVE

Lot Number 8023

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 11/28/2020

Event Type  Injury  

Manufacturer Narrative

Argus case us2020237240.

Event Description

And i almost choked [choking] dissolved in my throat [accidental device ingestion] case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 90-year-old female patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number 8023, expiry date 28th february 2023) for dental care.This case was associated with a product complaint.Concomitant products included no therapy.On 28th november 2020, the patient started super poligrip original (zinc free formula).On 28th november 2020, an unknown time after starting super poligrip original (zinc free formula), the patient experienced choking (serious criteria gsk medically significant).On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and product complaint.The action taken with super poligrip original (zinc free formula) was unknown.On 28th november 2020, the outcome of the choking was recovering/resolving.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown.The reporter considered the choking to be related to super poligrip original (zinc free formula).It was unknown if the reporter considered the accidental device ingestion to be related to super poligrip original (zinc free formula).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information was received via call center representative (phone) on 30 november 2020.The consumer stated that, "i just want to say to you, i told my son n law to get me something for my denture.He got me the poligrip and it worked on the bottom.I put the poligrip on my top dentures and it was really messy and dissolved in my throat and i almost choked.What's in this stuff? lot number 8023 with expiry date of february 2023." follow up information was received on 02 december 2020 from department of quality assurance (qa) regarding complaint 01386898 (product complaint number) for lot number 8023.No complaint sample was returned for this complaint.This complaint was considered to be unsubstantiated.The batch details were not received so a full investigation could not be completed.As this information was not available the complaint could not be substantiated.All of the documentation pertinent to a specific lot of finished product was contained in a batch envelope.Prior to the disposition of the product, the contents of each batch envelope was reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verified that all test results met specification requirements.This product was manufactured to the required standards and met all requirements of the release specification.Oozing of the product occurs when excessive product is applied to the denture.Directions for each tube states to use the minimum amount necessary to get maximum hold without having product ooze from the dentures.Both the initial and follow up information received was updated into the case.

• Brand Name: SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
• 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: 10986057
• MDR Text Key: 226333155
• Report Number: 3003721894-2020-00348
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2020

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
• Device Expiration Date: 02/28/2023
• Device Lot Number: 8023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/10/2020
• 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
• Patient Age: 90 YR