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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), corega tabs bio formula.Corega tabs bio formula is marketed as polident tablets in the us.

Event Description

Drinking the solution resulting from tablet dissolution [accidental device ingestion], back pain, lung disease, not feeling well.Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser 10791-02-001 (corega tabs bio formula) tablet for denture wearer.Concurrent medical conditions included osteoporosis.On an unknown date, the patient started corega tabs bio formula.On an unknown date, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant), back pain (serious criteria hospitalization), lung disease and feeling unwell.On an unknown date, the outcome of the accidental device ingestion, lung disease and feeling unwell were unknown and the outcome of the back pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, back pain, lung disease and feeling unwell to be related to corega tabs bio formula.Additional details: this case was reported by consumer's daughter.The following occurred during this christmas season.The reporter said that she brought to her mother corega tabs bio formula to use it for cleaning the prosthesis.But when she walked into her room, she saw her drinking the solution resulted from tablet dissolution in water.Right after this incident her mother did not reported any unusual symptoms.About 3 weeks ago, her mother started to accuse back pains.She was hospitalized for the back pains and on this occasion the doctors discovered that she was suffering from a lung disease.She asked the family doctor if her mother might be in danger because of that event, but the doctor said that he doesn't believe so after this period.The consumer's daughter is not sure that the current health problems are related to that event, however she is asking what could happen in this situation when her mother drank the solution.Currently her mother is not feeling well and she said that she will go with her to the doctor.

Event Description

Drinking the solution resulting from tablet dissolution [accidental device ingestion.Lung disease lung disease.Not feeling well feeling unwell.Stomach ache stomach pain.Abdominal bloating abdominal bloating.Lack of vitality energy decreased.Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a 81-year-old female patient who received double salt denture cleanser 10791-02-001 (corega tabs bio formula) tablet for denture wearer.Concurrent medical conditions included osteoporosis.On an unknown date, the patient started corega tabs bio formula.On an unknown date, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant), back pain (serious criteria hospitalization), lung disease and feeling unwell.On an unknown date, the outcome of the accidental device ingestion, lung disease and feeling unwell were unknown and the outcome of the back pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, back pain, lung disease and feeling unwell 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: this case was reported by consumer's daughter.The following occurred during this christmas season.The reporter said that she brought to her mother corega tabs bio formula to use it for cleaning the prosthesis.But when she walked into her room, she saw her drinking the solution resulted from tablet dissolution in water.Right after this incident her mother did not reported any unusual symptoms.About 3 weeks ago, her mother started to accuse back pains.She was hospitalized for the back pains and on this occasion the doctors discovered that she was suffering from a lung disease.She asked the family doctor if her mother might be in danger because of that event, but the doctor said that he doesn't believe so after this period.The consumer's daughter is not sure that the current health problems are related to that event, however she is asking what could happen in this situation when her mother drank the solution.Currently her mother is not feeling well and she said that she will go with her to the doctor.Followup was received on (b)(6) 2018: concurrent medical conditions included lung disease.On an unknown date, the patient started corega tabs bio formula.On an unknown date, an unknown time after starting corega tabs bio formula, the patient experienced cough, lung disorder (serious criteria hospitalization), stomach pain, abdominal bloating and energy decreased.On an unknown date, the outcome of the stomach pain, abdominal bloating and energy decreased were not recovered/not resolved and the outcome of the cough was not reported.It was unknown if the reporter considered the stomach pain, abdominal bloating and general energy decreased to be related to corega tabs bio formula.The reporter considered the back pain and cough to be unrelated to corega tabs bio formula.The reporter said that her mother was initially hospitalized for back pains and for coughing, but these symptoms were not related with the incident.At the time of reporting, she was no longer in the hospital.She said that lately, her mother occasionally accused of stomach ache, abdominal bloating and lack of vitality, but the reporter could not associate these symptoms with the incident.The reporter suggested us that it would be good if the packing of corega were clearer especially for the elderly, for example a prosthesis on the box.The patient stopped using corega tabs bio formula.

• Brand Name: COREGA TABS BIO FORMULA
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• MDR Report Key: 7331144
• MDR Text Key: 102119541
• Report Number: 1020379-2018-00017
• 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
• Report Date: 03/05/2018

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: 03/05/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 81 YR