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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2018-00041 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 product intake (accidental device ingestion).Burning sensation in the mouth (burning oral sensation).Case description: this case was reported by a pharmacist via call center representative and described the occurrence of accidental device ingestion in a (b)(6) female 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.In 2018, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and burning oral sensation.On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the burning oral sensation was not reported.It was unknown if the reporter considered the accidental device ingestion and burning oral sensation 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: a pharmacist reported about a female who had accidentally taken the dissolved corega tabs bio formula water in the mouth and had immediately spit it out as she had noticed a burning sensation in her mouth.The consumer immediately rinsed her mouth and had drunken chamomile tea.She had not experienced vomiting nor headaches.The consumer wanted to know what she should do now.

Manufacturer Narrative

Report 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

Case description: this case was reported by a pharmacist via call center representative and described the occurrence of accidental device ingestion in a 60-year-old female 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.In 2018, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and burning oral sensation.On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the burning oral sensation was not reported.It was unknown if the reporter considered the accidental device ingestion and burning oral sensation 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: a pharmacist reported about a female who had accidentally taken the dissolved corega tabs bio formula water in the mouth and had immediately spit it out as she had noticed a burning sensation in her mouth.The consumer immediately rinsed her mouth and had drunken chamomile tea.She had not experienced vomiting nor headaches.The consumer wanted to know what she should do now.Follow up information received via pharmacist on 06 aug 2018: the patient was 71-year-old.On an unknown date, the outcome of the burning oral sensation was recovered/resolved.The dissolved corega tabs bio formula water, had been mixed up with drinking water by accident, but been spit out immediately.Patient details updated.

• Brand Name: COREGA TABS BIO FORMULA
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 7733219
• MDR Text Key: 115526038
• Report Number: 1020379-2018-00041
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR