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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The report # 1020379-2018-00027 is associated with (b)(4), corega tabs.Corega tabs is marketed as polident tablets in the us.

Event Description

Accidental exposure to product [accidental device ingestion].Accidental exposure to product/ a cup full of water and drank, because he thought that the product it was sonrisal [wrong device used].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) 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 wrong device used.The action taken with corega tabs was unknown.On an unknown date, the outcome of the accidental device ingestion and wrong device used were not reported.It was unknown if the reporter considered the accidental device ingestion and wrong device used to be related to corega tabs.Additional details, the consumer contacted call center to related that his nephew inserted corega tabs in a cup full of water and drank, because he thought that the product it was sonrisal (accidental exposure to product).The consumer asked if had some problem in this exposure.

• Brand Name: COREGA TABS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7642593
• MDR Text Key: 112494346
• Report Number: 1020379-2018-00027
• 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: 06/21/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 06/27/2018
• 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