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

Lot Number DP3145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Patient reported swallowing corega product.[accidental device ingestion].It is causing me allergies/still experiencing "allergy [allergy].Starts to appear a liquid in the throat that goes down (as reported) [throat discomfort].It causes pricking/itchy throat [throat irritation].Case description: this case was reported by a consumer via call center representative and described the occurrence of allergy in a (b)(6)-year-old female patient who received denture adhesive powder-double salt (corega powder) oral powder for drug use for unknown indication.Co-suspect products included double salt dental adhesive cream (ultra corega flavor free) cream (batch number dp3145, expiry date december 2020) for drug use for unknown indication.On an unknown date, the patient started corega powder and ultra corega flavor free.On an unknown date, an unknown time after starting corega powder and ultra corega flavor free, the patient experienced allergy, throat discomfort and throat irritation.The action taken with corega powder was unknown.The action taken with ultra corega flavor free was unknown.On an unknown date, the outcome of the allergy, throat discomfort and throat irritation were unknown.It was unknown if the reporter considered the allergy, throat discomfort and throat irritation to be related to corega powder and ultra corega flavor free.Additional details: consumer bought the corega and it was causing her allergies.She applied it and started to appear a liquid in the throat that went down (as reported) and it caused pricking and itching.The two corega, both the powder and the cream.Medical history was not reported.Information regarding concomitant medications was not provided.Follow up received from a consumer on 06 jul 2020: on an unknown date, an unknown time after starting corega powder and ultra corega flavor free, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the allergy, throat discomfort and throat irritation were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion to be related to corega powder and ultra corega flavor free.The patient reported that she was still experiencing allergy, liquid that goes down her throat and pricking and causes itchy throat.She had already used three glasses of antiallergic syrup prescribed by the doctor and also pills, but she continued the same way.The patient did not know the name of the syrup or the pill.Patient reported swallowing corega product.

Event Description

Patient reported swallowing corega product.[accidental device ingestion] it is causing me allergies/still experiencing "allergy [allergy] starts to appear a liquid in the throat that goes down (as reported) [throat discomfort] it causes pricking/itchy throat [throat irritation], that she has a very strong cough [cough], nausea [nausea], she can't sleep at night [difficulty sleeping].Case description: this case was reported by a consumer via call center representative and described the occurrence of allergy in a 67-year-old female patient who received denture adhesive powder-double salt (corega powder) oral powder for drug use for unknown indication.Co-suspect products included double salt dental adhesive cream (ultra corega flavor free) cream (batch number dp3145, expiry date december 2020) for drug use for unknown indication.On an unknown date, the patient started corega powder and ultra corega flavor free.On an unknown date, an unknown time after starting corega powder and ultra corega flavor free, the patient experienced allergy, throat discomfort and throat irritation.The action taken with corega powder was unknown.The action taken with ultra corega flavor free was unknown.On an unknown date, the outcome of the allergy, throat discomfort and throat irritation were unknown.It was unknown if the reporter considered the allergy, throat discomfort and throat irritation to be related to corega powder and ultra corega flavor free.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: consumer bought the corega and it was causing her allergies.She applied it and started to appear a liquid in the throat that went down (as reported) and it caused pricking and itching.The two corega, both the powder and the cream.Medical history was not reported.Information regarding concomitant medications was not provided.Follow up received from a consumer on 06 jul 2020: on an unknown date, an unknown time after starting corega powder and ultra corega flavor free, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the allergy, throat discomfort and throat irritation were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion to be related to corega powder and ultra corega flavor free.The patient reported that she was still experiencing allergy, liquid that goes down her throat and pricking and causes itchy throat.She had already used three glasses of antiallergic syrup prescribed by the doctor and also pills, but she continued the same way.The patient did not know the name of the syrup or the pill.Patient reported swallowing corega product.Follow up received from a consumer on 13 aug 2020.Co-suspect products included double salt dental adhesive cream (corega denture adhesive cream) cream for product used for unknown indication.On an unknown date, the patient started corega denture adhesive cream.On an unknown date, an unknown time after starting corega denture adhesive cream, the patient experienced cough, nausea and difficulty sleeping.The action taken with corega denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion, cough, nausea and difficulty sleeping were unknown and the outcome of the allergy, throat discomfort and throat irritation were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, allergy, throat discomfort, throat irritation, cough, nausea and difficulty sleeping to be related to corega powder, ultra corega flavor free and corega 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.The patient reported that she went to the dentist, but nothing could be done.The dentist said that she could do an implant, however, the patient does not have the money since it is very expensive.The patient reported that she has allergies of corega powder and corega cream; she said she tried to use fixodent as well, but she also had allergy.The patient does not know what to do because, according to her, there is little bone in the mouth, the denture does not hold without fixation.The patient said that everything remains the same and said that the dentist instructed her to reduce the amount of corega.The patient reported that she decreased the amount, but continues swallowing it; it goes to the roof of her mouth, throat and causes itching.She also reported that she has a very strong cough and nausea.She also informed that she can't sleep at night, sometimes, because of that.Follow up information was received from consumer on 20 aug 2020, on an unknown date, the outcome of the cough was not recovered/not resolved.Patient informed that she was still presenting allergy, a lot of allergy, she need to remove the denture to sleep.The cough also continued, there were times when it attacks and there were times when it was very little.The above events occur as soon as the patient puts on corega.

Manufacturer Narrative

Argus case (b)(4).

• Brand Name: ULTRA COREGA FLAVOR FREE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 10294937
• MDR Text Key: 207924663
• Report Number: 3003721894-2020-00191
• 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: 06/25/2020

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
• Device Lot Number: DP3145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 78