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

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Mdr: 1020379-2019-00014 is associated with argus case (b)(4), corega tabs.Corega tabs is marketed as polident tablets in the us.

Event Description

Accidentally a quarter of a tab ingested (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 denture cleanser (corega tabs) tablet for drug use for unknown indication.On an unknown date, the patient started corega tabs.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant).The action taken with corega tabs was unknown.On an unknown date, the outcome of the accidental device ingestion by a child was not reported.It was unknown if the reporter considered the accidental device ingestion by a child to be related to corega tabs.Additional details: the patient's father reported that, accidentally the patient (one and half year old) ingested a quarter of a tab.No adverse reaction was reported.

• Brand Name: COREGA TABS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO, INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8389945
• MDR Text Key: 137811074
• Report Number: 1020379-2019-00014
• 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: 02/25/2019

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: Lay User/Patient
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/05/2019
• 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: 18 MO