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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

1020379-2016-00070 is associated with argus case (b)(4), corega tabs denture cleanser corega tabs denture cleanser is marketed as polident in the us.

Event Description

Accidental ingestion [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received gsk denture adhesive (formulation unknown) (corega) oral powder for product used for unknown indication.On an unknown date, the patient started corega.On an unknown date, an unknown time after starting corega, the patient experienced pain and wrong route of administration.On an unknown date, the outcome of the pain was not reported and the outcome of the wrong route of administration was unknown.It was unknown if the reporter considered the pain to be related to corega.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: patient informed that she used corega powder, but she was presenting pain (unspecified) during the removal of the product (not specified).Patient asked how she must remove the product.Besides that, patient informed that one of the times that she used corega powder she inhaled.So was registered drug administered via inappropriate route (medication error).The narrative of the patient was not very clear, it was a little confused and patient informed things without sense.Follow-up received on 25 november 2016: the consumer informed she drank water with dissolved corega tabs.On an unknown date, an unknown time after starting corega, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega.Correction from 25 november 2016: co-suspect products included denture cleanser (corega tabs) unknown for product used 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 (serious criteria gsk medically significant).It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs.

• Brand Name: COREGA TABS
• 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: 6169154
• MDR Text Key: 62315674
• Report Number: 1020379-2016-00070
• 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: 10/21/2016

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: 11/25/2016
• Initial Date FDA Received: 12/13/2016
• 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
• Patient Outcome(s): Other