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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Toxicity (2333)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Drank it.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 corega (corega tablets) unknown for denture wearer.On an unknown date, the patient started corega tablets.On (b)(6) 2016, an unknown time after starting corega tablets, the patient experienced device use error.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The patient was treated with omeprazole (losec) and maalox (nos) (maalox).On an unknown date, the outcome of the accidental device ingestion and device use error were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega tablets.Additional information the pharmacist reported that a (b)(6) woman who is using corega product (not specified which) for years now for her denture, dissolved it in water and drank it.At the moment of communication the information that the pharmacist had was that the women had no ae.She, however, will have as a treatment maalox and losec.No more information was available.

Manufacturer Narrative

This report is associated with argus case (b)(4), corega tablets.Corega tablets 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 (b)(6) female patient who received corega (corega tablets) unknown for denture wearer.On an unknown date, the patient started corega tablets.On (b)(6) 2016, an unknown time after starting corega tablets, the patient experienced device use error.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The patient was treated with omeprazole (losec) and maalox (nos) (maalox).On an unknown date, the outcome of the accidental device ingestion and device use error were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega tablets.Additional information the pharmacist reported that a (b)(6) woman who is using corega product (not specified which) for years now for her denture, dissolved it in water and drank it.At the moment of communication the information that the pharmacist had was that the women had no ae.She, however, will have as a treatment maalox and losec.No more information was available.Follow up received on 08 dec 2016.The pharmacist confirmed that the patient used maalox and losec as treatment for the medication error and according to her knowledge the patient experienced no ae.

• Brand Name: COREGA 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: 6144307
• MDR Text Key: 61433664
• Report Number: 1020379-2016-00067
• 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: 11/21/2016

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
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• 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: 83 YR