MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA TABS 3 MINUTEN; DENTURE CLEANSER

Lot Number MH141724A

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The 1020379-2018-00020 is associated with argus case (b)(4), corega tabs 3 minuten.Corega tabs 3 minuten is marketed as polident in the us.

Event Description

Thrombosis.Cholesterol.Hypertension.Osteoporosis.Case description: this case was reported by a consumer via call center representative and described the occurrence of thrombosis in a female patient who received double salt denture cleanser (corega tabs 3 minuten) tablet (batch number mh141724a, expiry date august 2019) for prosthesis user.This case was associated with a product complaint.On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced thrombosis (serious criteria gsk medically significant), cholesterol, hypertension, osteoporosis and product complaint.The action taken with corega tabs 3 minuten was unknown.On an unknown date, the outcome of the thrombosis was not reported and the outcome of the cholesterol, hypertension, osteoporosis and product complaint were unknown.It was unknown if the reporter considered the thrombosis, cholesterol, hypertension and osteoporosis to be related to corega tabs 3 minuten.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, the consumer informed the patient could not go to the street because she had thrombosis in both legs.She said she used corega for more than 15 years and the thrombosis appeared short time ago.She also said she would given the list of all the medicines she taken.She taken remedy for thrombosis, for cholesterol, for hypertension and for osteoporosis.So, she did not specified which medicines she had been taken.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of thrombosis in a female patient who received double salt denture cleanser (corega tabs 3 minuten) tablet (batch number mh141724a, expiry date august 2019) for prosthesis user.This case was associated with a product complaint.On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced thrombosis (serious criteria gsk medically significant), cholesterol, hypertension, osteoporosis and product complaint.The action taken with corega tabs 3 minuten was unknown.On an unknown date, the outcome of the thrombosis was not reported and the outcome of the cholesterol, hypertension, osteoporosis and product complaint were unknown.It was unknown if the reporter considered the thrombosis, cholesterol, hypertension and osteoporosis to be related to corega tabs 3 minuten.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, the consumer informed the patient could not go to the street because she had thrombosis in both legs.She said she used corega for more than 15 years and the thrombosis appeared short time ago.She also said she would given the list of all the medicines she taken.She taken remedy for thrombosis, for cholesterol, for hypertension and for osteoporosis.So, she did not specified which medicines she had been taken.Follow up information was received for correction on 19 mar 2018, the initial case was opened the product complaint by call center, but this investigation it was not related to adverse event.Therefore, the event product complaint should not had been added for this case, so would exclude the event product complaint.

Manufacturer Narrative

1020379-2018-00020 is associated with argus case (b)(4), corega tabs 3 minuten.Corega tabs 3 minuten is marketed as polident in the us.

• Brand Name: COREGA TABS 3 MINUTEN
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• MDR Report Key: 7375589
• MDR Text Key: 103657462
• Report Number: 1020379-2018-00020
• Device Sequence Number: 1
• Product Code: EFT
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Lot Number: MH141724A
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other