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

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Abdominal Pain (1685)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

The 1020379-2016-00043 is associated with argus case (b)(4), corega tablets.Corega tablets is marketed as polident tablets in the us.

Event Description

Drunk tablet in water [accidental device ingestion].Stomach ache [stomach pain].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) male patient who received corega (corega tablets) dispersible tablet for drug use for unknown indication.On (b)(6) 2016, the patient started corega tablets.On (b)(6) 2016, an unknown time after starting corega tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On (b)(6) 2016 11:00, the patient experienced stomach pain.On (b)(6) 2016, the outcome of the accidental device ingestion was recovered/resolved.On (b)(6) 2016 15:30, the outcome of the stomach pain was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion to be related to corega tablets.The reporter considered the stomach pain to be related to corega tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.

• Brand Name: COREGA 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: 5974037
• MDR Text Key: 55560507
• Report Number: 1020379-2016-00043
• 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: 09/09/2016

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: 09/09/2016
• Initial Date FDA Received: 09/23/2016
• 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: 72 YR