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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

1020379-2018-00073 is associated with argus case (b)(4), corega tabs whitening.Corega tabs whitening is marketed as polident tablets in the us.

Event Description

He swallowed the tablet [accidental device ingestion].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 denture cleanser (corega tabs whitening) tablet for denture wearer.On an unknown date, the patient started corega tabs whitening.On (b)(6) 2018, an unknown time after starting corega tabs whitening, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with corega tabs whitening was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs whitening.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 reported that his father swallowed one tablet of corega tabs whitening denture cleanser on (b)(6) 2018 morning.His son called to inquired whether it can cause any trouble.

Manufacturer Narrative

Initial report is associated with argus case (b)(4), corega tabs whitening.Corega tabs whitening is marketed as polident tablets in the us.

Event Description

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 denture cleanser (corega tabs whitening) tablet for denture wearer.On an unknown date, the patient started corega tabs whitening.On (b)(6) 2018, an unknown time after starting corega tabs whitening, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with corega tabs whitening was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs whitening.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 reported that his father swallowed one tablet of corega tabs whitening denture cleanser on (b)(6) 2018 morning.His son called to inquired whether it can cause any trouble.Follow up information was received from patient's son on (b)(6) 2018, this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 80-year-old male patient who received denture cleanser (corega tabs whitening) tablet for denture wearer.Concurrent medical conditions included diabetes and heart disease, unspecified.On an unknown date, the patient started corega tabs whitening at an unknown dose and frequency.The reporter considered the accidental device ingestion to be unrelated to corega tabs whitening.The reporter stated that no any symptoms occurred after swallowing of corega tabs whitening, they did not visit general practitioner.No any symptoms had experienced at that time.In patient's medical history diabetes and heart disease was found on the unknown date and treated with unknown drugs in unknown dose.(son had no list about took medication) batch no was not reported.Reporter, the son, did not consider the case suspect drug related, he supposed the case happened in chance, his father had confused it with a piece of sugar in the dark.Comment: downgrade report.

• Brand Name: COREGA TABS WHITENING
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 8174381
• MDR Text Key: 130987856
• Report Number: 1020379-2018-00073
• 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: 12/12/2018

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: 12/12/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR