MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA; UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Nausea (1970)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), corega.Corega is marketed as super poligrip in the us.

Event Description

Accidental ingestion/swallowing too much product [accidental device ingestion].Nausea [nausea].Doing harm to his blood pressure [blood pressure abnormal].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received corega unknown for product used for unknown indication.This case was associated with a product complaint.Concurrent medical conditions included diabetes, periodontitis and blood pressure high.On an unknown date, the patient started corega.On an unknown date, an unknown time after starting corega, the patient experienced accidental device ingestion (serious criteria gsk medically significant), nausea, blood pressure abnormal and product complaint.On an unknown date, the outcome of the accidental device ingestion, nausea and product complaint were not reported and the outcome of the blood pressure abnormal was unknown.The reporter considered the accidental device ingestion and nausea to be related to corega.It was unknown if the reporter considered the blood pressure abnormal to be related to corega.Additional details: the action taken with corega was unknown.The consumer(patient) informed his dissatisfaction with corega.Patient was afraid of swallowing too much product and that did harm to his blood pressure.

• Brand Name: COREGA
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7480688
• MDR Text Key: 107152580
• Report Number: 3003721894-2018-00139
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• 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