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

Lot Number KR3V

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

1020379-2019-00008 is associated with argus case (b)(4), corega whitening.Corega whitening is marketed as polident tablets in the us.

Event Description

Medication error with no harm; drunk yesterday half of the amount of corega solution from the cup that she puts her denture [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 (b)(6)-year-old female patient who received denture cleanser (corega whitening) tablet (batch number kr3v, expiry date march 2021) for drug use for unknown indication.Concurrent medical conditions included dementia.On an unknown date, the patient started corega whitening.On (b)(6) 2019, an unknown time after starting corega whitening, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Corega whitening was continued with no change.On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega whitening.Additional details: initial and follow up processed together.The reporter reported on (b)(6) 2019 to the hub that her mother, who was suffering from dementia, drunk yesterday half of the amount of corega solution from the cup that she puts her denture (corega whitening, denture cleanser, ticket has been raised to add the exact product in argus).She gave to her mother milk and a lot of water, she did not vomit and fell asleep.She said that she did not look like she had a problem.We called today for more details.Reporter's mother by mistake drunk the solution on (b)(6) 2019.She had not experienced an adverse event and continued the use of corega whitening, as she was doing for years.She did not want to give more details for the dementia.Her mother was well.

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 87-year-old female patient who received denture cleanser (corega whitening) tablet (batch number kr3v, expiry date march 2021) for drug use for unknown indication.Concurrent medical conditions included dementia.On an unknown date, the patient started corega whitening.On (b)(6) 2019, an unknown time after starting corega whitening, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Corega whitening was continued with no change.On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega 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: initial and follow up processed together.The reporter reported on (b)(6) 2019 to the hub that her mother, who was suffering from dementia, drunk yesterday half of the amount of corega solution from the cup that she puts her denture (corega whitening, denture cleanser, ticket has been raised to add the exact product in argus).She gave to her mother milk and a lot of water, she did not vomit and fell asleep.She said that she did not look like she had a problem.We called today for more details.Reporter's mother by mistake drunk the solution on (b)(6) 2019.She had not experienced an adverse event and continued the use of corega whitening, as she was doing for years.She did not want to give more details for the dementia.Her mother was well.Follow up information was received on 05 feb 2019.The suspect drug trade name changed to corega whitening in initial version of case, so follow up was routed as non significant follow up.The follow up information was received on 28 feb 2019, the reporter's mother had not experienced an adverse event and she was well.She continued the use of corega as denture cleaning.

• Brand Name: COREGA WHITENING
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 8326223
• MDR Text Key: 136127916
• Report Number: 1020379-2019-00008
• 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: 01/31/2019

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
• Device Lot Number: KR3V
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR