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

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

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

A 1020379-2016-00074 is associated with argus case (b)(4), corega tabs bio formula.Corega tabs bio formula is marketed as polident tablets in the us.

Event Description

Accidental intake of granules of lid by child/ child swallowed granules out of the lid.[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) old male patient who received double salt denture cleanser (b)(4) (corega tabs bio formula) tablet for drug use for unknown indication.On an unknown date, the patient started corega tabs bio formula.On an unknown date, 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 unknown.It was unknown if the reporter considered the accidental device ingestion by a child to be related to corega tabs bio formula.

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) male 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 an unknown date, 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 unknown.It was unknown if the reporter considered the accidental device ingestion by a child to be related to corega tabs bio formula.Case correction from initial receipt date: this case described the occurrence of accidental ingestion of product desiccant by child in a (b)(6) male 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 an unknown date, an unknown time after starting corega tabs bio formula, the patient experienced accidental ingestion of product desiccant by child.On an unknown date, the outcome of the accidental ingestion of product desiccant by child was unknown.Comment: *downgrade report*.

• 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: 6202705
• MDR Text Key: 63232816
• Report Number: 1020379-2016-00074
• 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: 08/12/2016

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: 08/12/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• 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: 14 MO