MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA TABS 3 MINUTEN; DENTURE CLEANSER

Lot Number MJ071524A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Irritation (1941); Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

Report # 1020379-2017-00013 is associated with (b)(4), corega tabs 3 minuten.Corega tabs 3 minuten is marketed as polident in the u.S.

Event Description

Throat irritation [throat irritation]; accidental ingestion [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of throat irritation in a (b)(6) year-old female patient who received double salt denture cleanser (corega tabs 3 minuten) tablets (batch number mj071524a, expiry date october 2017) for unknown indication.Concurrent medical conditions included back pain, abdominal pain and chronic pain (under treatment from psychiatrist).On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced throat irritation and accidental device ingestion (serious criteria gsk medically significant).The action taken with corega tabs 3 minuten was unknown.On an unknown date, the outcome of the throat irritation and accidental device ingestion were unknown.It was unknown if the reporter considered the throat irritation and accidental device ingestion to be related to corega tabs 3 minuten.Additional details: this case was reported by the patient's husband.It was reported that the patient had accidentally swallowed the product a few times.Since then, the patient had been experiencing throat irritation.

• Brand Name: COREGA TABS 3 MINUTEN
• 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: 6300626
• MDR Text Key: 66491500
• Report Number: 1020379-2017-00013
• 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: 01/26/2017

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
• Device Lot Number: MJ071524A
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/03/2017
• 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: 43 YR
• Patient Weight: 84