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

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

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The 1020379-2017-00038 is associated with argus case (b)(4), corega tabs.Corega tabs is marketed in the us as polident tablets.

Event Description

Accidental ingesta [accidental device ingestion]; drowning for trying to swallow the tablet but nothing happened [swallowing difficult]; discomfort [discomfort].Case description: this case was reported by a dentist via call center representative and described the occurrence of accidental device ingestion in a (b)(6) male patient who received denture cleanser (corega tabs) unknown for denture wearer.Concurrent medical conditions included renal impairment (controlled).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), swallowing difficult and discomfort.On an unknown date, the outcome of the accidental device ingestion was recovered/resolved and the outcome of the swallowing difficult and discomfort were unknown.It was unknown if the reporter considered the accidental device ingestion, swallowing difficult and discomfort to be related to corega tabs.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 information processed together.Initial adverse event report from dentist received on 03-may-2017 through call center.The dentist commented that a (b)(6) male patient had an accidental ingesta of corega tabs, he said that this was the first time the patient went with him.He said that the patient's weight is (b)(6).The dentist commented that he had not talked with the patient so, he could not give more information about the outcome of the event.On 09-may-2017 the dentist commented that the patient was ok, he had any discomfort except that he was drowning for trying to swallow the tablet but nothing happened.

• Brand Name: COREGA TABS
• 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: 6570479
• MDR Text Key: 75307773
• Report Number: 1020379-2017-00038
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 05/03/2017

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: 05/03/2017
• Initial Date FDA Received: 05/16/2017
• 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: 93 YR