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

Lot Number UNKNOWN

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Son drank corega tabs bioformula [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 male patient who received denture cleanser (corega tabs bio formula) tablet for product used 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).The action taken with corega tabs bio formula was unknown.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.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: consumer reported that his son, drank corega tabs bioformula in an unguarded moment.

• Brand Name: COREGA TABS BIO FORMULA
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis; TN
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 11165678
• MDR Text Key: 226779129
• Report Number: 1020379-2020-00067
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/20/2020
• 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