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

Device Problem Human Factors Issue (2948)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 06/15/2017

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 in the us.

Event Description

Accidental exposure [accidental device ingestion by a child].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a (b)(6) female patient who received double salt denture cleanser 10791-02-001 (corega tabs bio formula) tablet for drug use for unknown indication.On an unknown date, the patient started corega tabs bio formula.On (b)(6) 2017, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion by a child was recovered/resolved.The reporter considered the accidental device ingestion by a child to be related to corega tabs bio formula.Additional information: case reported to pv through call centre representative.(b)(6) female drank some liquid with corega oxigeno bioactivo (accidental exposure) on (b)(6) 2017.She was advised to go to hospital emergency room for examination.On 19/06/2017 pv contacted for fu information.The patient did not present any adverse event but as precaution, they went to hospital emergency room for examination.At medical examination, the patient did not present any event so no treatment was prescribed.At reporting date no events had appeared.The case is closed.

Manufacturer Narrative

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

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a (b)(6) female patient who received double salt denture cleanser 10791-02-001 (corega tabs bio formula) tablet for drug use for unknown indication.On an unknown date, the patient started corega tabs bio formula.On (b)(6) 2017, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion by a child was recovered/resolved.The reporter considered the accidental device ingestion by a child to be related to corega tabs bio formula.Additional information case reported to pv through call centre representative.(b)(6) female drank some liquid with corega oxigeno bioactivo (accidental exposure) on (b)(6) 2017.She was advised to go to hospital emergency room for examination.On 19/06/2017 pv contacted for fu information.The patient did not present any adverse event but as precaution, they went to hospital emergency room for examination.At medical examination, the patient did not present any event so no treatment was prescribed.At reporting date no events had appeared.The case is closed.Follow up information received 06 july 2017 the event occurred on (b)(6) 2017 and she went to emergency room for examination on (b)(6) 2017.

• 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: 6689085
• MDR Text Key: 79143388
• Report Number: 1020379-2017-00050
• 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,Followup
• Report Date: 06/15/2017

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: 06/15/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 07/13/2017
• 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: 15 MO