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

Lot Number 091724

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

(b)(4) is associated with (b)(4), corega tabs.Corega tabs is marketed as polident tablets in the us.

Event Description

Accidental exposure [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 patient who received denture cleanser (corega tabs) tablet (batch number 091724, expiry date january 2019) 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).The action taken with corega tabs was unknown.On an unknown date, the outcome of the accidental device ingestion was recovered/resolved.The reporter considered the accidental device ingestion to be related to corega tabs.Additional details: the consumer informed that he used the product corega tabs and he forgotten to wash his dental prosthesis before to put in his mouth, and he experienced a flavor of soap in his mouth (accidental exposure).However, it happened only one time according to consumer.

• 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: 7637372
• MDR Text Key: 112300659
• Report Number: 1020379-2018-00028
• 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: 06/18/2018

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
• Device Lot Number: 091724
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 06/26/2018
• 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