MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA ULTRA POWDER; DENTURE ADHESIVE

Lot Number BN8G

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I came close to dying [near death experience].Mucous membranes swell up [mucosal swelling].Mucous membranes become closed [pharynx closed sensation of].Cannot drink or eat [unable to swallow].Case description: this case was reported by a consumer via call center representative and described the occurrence of near death experience in a (b)(6) male patient who received denture adhesive powder-double salt (corega ultra powder) oral powder (batch number bn8g, expiry date 30th april 2024) for denture wearer.This case was associated with a product complaint.On (b)(6) 2020, the patient started corega ultra powder.On an unknown date, an unknown time after starting corega ultra powder, the patient experienced near death experience (serious criteria gsk medically significant), mucosal swelling, pharynx closed sensation of, unable to swallow and product complaint.The action taken with corega ultra powder was unknown.On an unknown date, the outcome of the near death experience, mucosal swelling, pharynx closed sensation of, unable to swallow and product complaint were unknown.It was unknown if the reporter considered the near death experience, mucosal swelling, pharynx closed sensation of and unable to swallow to be related to corega ultra powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: patient need information about this product.Ultra powder corega.When put the powder in, it dissolves and creates congestion and patient could not drink or eat.His mucous membranes swell up and become closed.He came close to dying.It creates this layer of gel.This was fact, not fiction.Otherwise the products had been good.This was otherwise difficult.

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 near death experience in a 58-year-old male patient who received denture adhesive powder-double salt (corega ultra powder) oral powder (batch number bn8g, expiry date 30th april 2024) for denture wearer.This case was associated with a product complaint.On (b)(6) 2020, the patient started corega ultra powder.On an unknown date, an unknown time after starting corega ultra powder, the patient experienced near death experience (serious criteria gsk medically significant), mucosal swelling, pharynx closed sensation of, unable to swallow and product complaint.The action taken with corega ultra powder was unknown.On an unknown date, the outcome of the near death experience, mucosal swelling, pharynx closed sensation of, unable to swallow and product complaint were unknown.It was unknown if the reporter considered the near death experience, mucosal swelling, pharynx closed sensation of and unable to swallow to be related to corega ultra powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: patient need information about this product.Ultra powder corega.When put the powder in, it dissolves and creates congestion and patient could not drink or eat.His mucous membranes swell up and become closed.He came close to dying.It creates this layer of gel.This was fact, not fiction.Otherwise the products had been good.This was otherwise difficult.Follow up information received from quality assurance department on 17 dec 2020 pqc reference id (b)(4) and batch lot bn8g: the quality assurance department revealed the product complaint to be unsubstantiated.Follow up information was received on 21 dec 2020 from quality assurance (qa) department regarding complaint (b)(4) (complaint reference) for (bn8g) lot number.Pqc evaluation: no sample was returned for this complaint so a full investigation could not be completed.The batch number provided is also invalid.On this basis we are unable to investigate this complaint further.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.Quality assurance analysis revealed the complaint to be unsubstantiated.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of near death experience in a 58-year-old male patient who received denture adhesive powder-double salt (corega ultra powder) oral powder (batch number bn8g, expiry date 30th april 2024) for denture wearer.This case was associated with a product complaint.On (b)(6) 2020, the patient started corega ultra powder.On an unknown date, an unknown time after starting corega ultra powder, the patient experienced near death experience (serious criteria gsk medically significant), mucosal swelling, pharynx closed sensation of, unable to swallow and product complaint.The action taken with corega ultra powder was unknown.On an unknown date, the outcome of the near death experience, mucosal swelling, pharynx closed sensation of, unable to swallow and product complaint were unknown.It was unknown if the reporter considered the near death experience, mucosal swelling, pharynx closed sensation of and unable to swallow to be related to corega ultra powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: patient need information about this product.Ultra powder corega.When put the powder in, it dissolves and creates congestion and patient could not drink or eat.His mucous membranes swell up and become closed.He came close to dying.It creates this layer of gel.This was fact, not fiction.Otherwise the products had been good.This was otherwise difficult.Follow up information received from quality assurance department on 17 dec 2020 pqc reference id (b)(4) and batch lot bn8g: the quality assurance department revealed the product complaint to be unsubstantiated.Follow up information was received on 21 dec 2020 from quality assurance (qa) department regarding complaint ((b)(4)) (complaint reference) for (bn8g) lot number.Pqc evaluation: no sample was returned for this complaint so a full investigation could not be completed.The batch number provided is also invalid.On this basis we are unable to investigate this complaint further.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.Quality assurance analysis revealed the complaint to be unsubstantiated.Follow up information was received on 25 jan 2021 from quality assurance (qa) department regarding complaint ((b)(4)) (complaint reference) for (bn8g) lot number.Pqc evaluation: no sample was returned for this complaint so a full investigation could not be completed.The batch number provided is also invalid.On this basis we are unable to investigate this complaint further.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.Quality assurance analysis revealed the complaint to be unsubstantiated.

Manufacturer Narrative

Argus case (b)(4).

• Brand Name: COREGA ULTRA POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan; waterford, ; EI
• MDR Report Key: 11004505
• MDR Text Key: 226247514
• Report Number: 3003721894-2020-00354
• 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,Followup
• Report Date: 12/07/2020

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: 04/30/2024
• Device Lot Number: BN8G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/17/2020; 01/25/2021
• Supplement Dates FDA Received: 01/06/2021; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 58 YR