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

Device Problems Improper or Incorrect Procedure or Method (2017); Application Program Problem: Medication Error (3198)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Mfr 1020379-2017-00063 is associated with argus case (b)(4), corega denture cleansing tablets.Corega denture cleansing tablets are marketed as polident in the us.

Event Description

Medication error without harm / accidentally orally administered solution of corega denture tablets [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a elderly unk patient who received double salt denture cleanser 10791-02-001 (corega denture cleansing tablets) tablet for product used for unknown indication.On an unknown date, the patient started corega denture cleansing tablets.On an unknown date, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.The reporter considered the accidental device ingestion to be related to corega denture cleansing tablets.Additional details: reporter called and asked for consultation.An elderly consumer (gender not specified) accidentally orally administered solution of corega denture tablets.1 tablet had been dissolved in that solution.Consumer was referred to contact hcp.

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a elderly unk patient who received double salt denture cleanser (b)(6) (corega denture cleansing tablets) tablet for product used for unknown indication.On an unknown date, the patient started corega denture cleansing tablets.On an unknown date, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.The reporter considered the accidental device ingestion to be related to corega denture cleansing tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: reporter called and asked for consultation.An elderly consumer (gender not specified) accidentally orally administered solution of corega denture tablets.1 tablet had been dissolved in that solution.Consumer was referred to contact hcp.Follow up received on 31-aug-2017: reporter provided information that report concerns (b)(6) years old male.After accidental use of corega tablet solution no adverse reactions observed.

Manufacturer Narrative

1020379-2017-00063 is associated with argus case (b)(4), corega denture cleansing tablets.Corega denture cleansing tablets are marketed as polident in the us.Medical device assessment concluded (b)(6) 2017: tablets mistaken for candy, antacids, or other products, intended for ingestion.The denture tablets are compromised of ingredients that would impart a bitter and astringent taste.In the event tablet is place in mouth, it is expected that the consumer would remove it immediately due to the offensive taste.No sample or batch details were available; therefore no investigation can be performed.No root cause or conclusion can be determined, no capa's can be put in place.

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a elderly unk patient who received double salt denture cleanser (b)(4) (corega denture cleansing tablets) tablet for product used for unknown indication.On an unknown date, the patient started corega denture cleansing tablets.On an unknown date, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.The reporter considered the accidental device ingestion to be related to corega denture cleansing tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: reporter called and asked for consultation.An elderly consumer (gender not specified) accidentally orally administered solution of corega denture tablets.1 tablet had been dissolved in that solution.Consumer was referred to contact hcp.Follow up received on 31-aug-2017: reporter provided information that report concerns (b)(6) years old male.After accidental use of corega tablet solution no adverse reactions observed.Follow-up information received on 25 october 2017 from manufacturer complaint department.It was concluded that the event was assessed as non reportable as per medical device assessment.The complaint was considered as not substantiated and considered to be closed.

Manufacturer Narrative

1020379-2017-00063 is associated with argus case (b)(4), corega denture cleansing tablets.Corega denture cleansing tablets are marketed as polident in the us.Medical device assessment concluded (b)(6) 2017: tablets mistaken for candy, antacids, or other products, intended for ingestion.The denture tablets are compromised of ingredients that would impart a bitter and astringent taste.In the event tablet is place in mouth, it is expected that the consumer would remove it immediately due to the offensive taste.No sample or batch details were available; therefore no investigation can be performed.No root cause or conclusion can be determined, no capa's can be put in place.Fu3: follow-up 2 was submitted on 01 november 2017 and failed to have the qa results attached.Follow-up 3 was generated to include the qa results.No new follow-up information was received.

• Brand Name: COREGA DENTURE CLEANSING TABLETS
• 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: 6778610
• MDR Text Key: 82424639
• Report Number: 1020379-2017-00063
• 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,Followup,Followup,Followup
• Report Date: 08/02/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 08/31/2017; 10/25/2017; 10/25/2017
• Supplement Dates FDA Received: 09/14/2017; 11/01/2017; 11/20/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 75 YR