MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA STRONG DENTURE FIXATIVE CREAM; DENTURE ADHESIVE

Lot Number 595H

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

Patient Problem Cough (4457)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Swallowed a lot of denture fixative [accidental device ingestion]; he has had a cough [cough]; throat has been irritated [throat irritation].Case description: this case was reported by a consumer via call center representative (phone) and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (corega strong denture fixative cream) cream (batch number 595h, expiry date april 2024) for drug use for unknown indication.On an unknown date, the patient started corega strong denture fixative cream.On an unknown date, an unknown time after starting corega strong denture fixative cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), cough and throat irritation.On an unknown date, the outcome of the accidental device ingestion, cough and throat irritation were unknown.It was unknown if the reporter considered the accidental device ingestion, cough and throat irritation to be related to corega strong denture fixative cream.Additional information:the adverse event information was received from consumer via call center representative (phone) on 14jan2022 and consumer reported that"he swallowed a lot of denture fixative and since then, his throat has been irritated and he has had a cough.He could not tell the swallowed quantity.I suggested him to see a doctor and i assured him that i would forward the case.The caller was his mother".

• Brand Name: COREGA STRONG DENTURE FIXATIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park,, NC 27709 ; 8888255249
• MDR Report Key: 13357582
• MDR Text Key: 289224563
• Report Number: 3003721894-2022-00010
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2022

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: 595H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Sex: Male