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

Lot Number 3D13423

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus (b)(4) corega tabs bio formula.Corega tabs bio formula is marketed as polident tablets in the us.

Event Description

Drank the cleaning solution [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) male patient who received double salt denture cleanser 10791-02-001 (corega tabs bio formula) tablet (batch number (b)(4), expiry date october 2016) for denture wearer.The patient's past medical history included colon cancer and gallstones.Concomitant products included vinpocetine (cavinton), tervalon (nos) (tervalon) and duodenum extract, pancreatin, duodenum extract, pancreatin (dipankrin).On (b)(6) 2016, the patient started corega tabs bio formula.On (b)(6) 2016, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On (b)(6) 2016, the outcome of the accidental device ingestion was recovered/resolved.The reporter considered the accidental device ingestion to be related to corega tabs bio formula.Additional details: the patient dissolved 0,5 tablet in 1.5 dl water and drank three times one-one sip on (b)(6) 2016 in the morning.The patient had no symptoms or complaint so the case resolved immediately.The patient did not visit physician.The patient blood pressure was normal.

• Brand Name: COREGA TABS BIO FORMULA
• 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: 5663237
• MDR Text Key: 45441837
• Report Number: 1020379-2016-00009
• 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: 05/09/2016

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
• Device Expiration Date: 10/31/2016
• Device Lot Number: 3D13423
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 05/18/2016
• 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
• Treatment: CAVINTON (VINPOCETINE)
• Patient Outcome(s): Other
• Patient Age: 72 YR