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

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

Patient Problem Injury (2348)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), corega denture cleansing tablets.Corega denture cleansing tablets is marketed in the us as polident denture cleansing tablets.

Event Description

Accidentally exposure/ the patient swallowed.[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) female patient who received double salt denture cleanser 10791-02-001 (corega denture cleansing tablets) tablet for denture wearer.On an unknown date, the patient started corega denture cleansing tablets.On (b)(6) 2016, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On (b)(6) 2016, 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accidental device ingestion to be related to corega denture cleansing tablets.Additional information: the device was withdrawn at an unknown time.

• Brand Name: COREGA DENTURE CLEANSING TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6069024
• MDR Text Key: 58845302
• Report Number: 1020379-2016-00053
• 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: 03/28/2016

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: No Information
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 11/01/2016
• 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
• Patient Age: 82 YR