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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Swallowed a tablet [accidental device ingestion].She claims she split it in half.Wrong technique in device usage process.Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a elderly female patient who received denture cleanser (corega tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started corega tablets.On an unknown date, an unknown time after starting corega tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and wrong technique in device usage process.The action taken with corega tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to corega tablets.This report is made by gsk/(b)(6) without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from a consumer via call center representative on 29nov2022.It was reported that "an elderly woman swallowed a tablet, due to the size of the tablet, she claims she split it in half and both halves.It was recommended to refer to the er to receive medical consultation".

Manufacturer Narrative

Argus case: (b)(4).

Manufacturer Narrative

Argus case id: (b)(6).

Event Description

Swallowed a tablet [accidental device ingestion] burning sensation in her eyes [burning sensation in eye] she claims she split it in half [wrong technique in device usage process] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a elderly female patient who received denture cleanser (corega tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started corega tablets.On an unknown date, an unknown time after starting corega tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and wrong technique in device usage process.The action taken with corega tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to corega tablets.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details : adverse event information was received from a consumer via call center representative on 29nov2022.It was reported that "an elderly woman swallowed a tablet, due to the size of the tablet, she claims she split it in half and both halves.It was recommended to refer to the er to receive medical consultation".Follow up information was received on 20dec2022.Consumer stated that, the patient female is 63 years old, born in 1959 after she swallowed the corega tablet, they did not go to the emergency room but went to the family doctor.He had her undergo several tests her son could not specify which tests and said that there was no need to go to the emergency room, but to monitor her condition and if there was any worsening, they should go.The patient felt a burning sensation in her eyes and related it to the tablet she swallowed, although she still suffers from eye problems and has had surgery on both eyes for glaucoma and cataracts and takes 3-4 types of eye drops on a daily basis.About 5-7 days later, the phenomenon of burning in her eyes resolved without special treatment.In any case, she was scheduled to see an ophthalmologist for further follow-up.Patient age, birth year, pre-existing diseases eye problems (eye disorder), glaucoma and cataracts were added, physician office visit checkbox ticked.New event burning sensation in eye was added with causality yes and outcome as recovered/resolved.

• Brand Name: COREGA TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 16035911
• MDR Text Key: 306020399
• Report Number: 1020379-2022-00036
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/06/2023
• 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: 63 YR
• Patient Sex: Female