MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); TOOTHPASTES

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

Patient Problem Suffocation (2088)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I almost died suffocated [suffocation].Case description: this case was reported by a consumer via interactive digital media - (b)(6) and described the occurrence of suffocation in a male patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for dental prosthesis user.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser) at an unknown dose and frequency.On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced suffocation (serious criteria gsk medically significant).The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the suffocation was unknown.It was unknown if the reporter considered the suffocation to be related to corega (unspecified denture adhesive or denture cleanser).Additional information: patient reported information regarding suspect product corega.It was a lie, he was brushing the teeth with that toothpaste, he almost died suffocated.

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: TOOTHPASTES
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 9925689
• MDR Text Key: 196938436
• Report Number: 3003721894-2019-00260
• 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
• Report Date: 08/25/2019

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
• Initial Date Manufacturer Received: 08/25/2019
• Initial Date FDA Received: 04/03/2020
• 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
• Patient Outcome(s): Other