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

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

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Mfr report # 1020379-2018-00063 is associated with argus case (b)(4), corega tabs.Corega tabs are marketed as polident tablets in the us.

Event Description

Accidental ingestion [accidental device ingestion].Burning sensation on mouth [burning oral sensation].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (corega tabs) tablet for product used for unknown indication.On an unknown date, the patient started corega tabs.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and burning oral sensation.On an unknown date, the outcome of the accidental device ingestion was recovered/resolved and the outcome of the burning oral sensation was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs.The reporter considered the burning oral sensation to be related to corega tabs.Additional details: the reporter had informed that her mother felt burning sensation on the mouth when she accidentally ingested the suspect product.The age or age group were not reported.The batch was not reported.

• Brand Name: COREGA TABS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7970509
• MDR Text Key: 123958095
• Report Number: 1020379-2018-00063
• 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
• Report Date: 10/11/2018

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: 10/11/2018
• Initial Date FDA Received: 10/16/2018
• 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