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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Vomiting (2144); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Mfr report 1020379-2018-00060 is associated with argus case (b)(4), corega tablets.Corega tablets are marketed as polident tablets in the us.

Event Description

Accidental ingestion (medication error with harm) [accidental device ingestion], vomiting [vomiting].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received denture cleanser (corega tablets) tablet for drug use 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 vomiting.The action taken with corega tablets was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the vomiting was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tablets.The reporter considered the vomiting to be related to corega tablets.Additional details: the patient (gender unspecified) accidentally ingested two tablets of corega denture cleanser (type unspecified).On (b)(6) 2018, the reporter contacted gsk call center and informed that the patient went to the hospital just to make sure that nothing bad was happened, the patient was told at the hospital that the reaction to vomit was correct and if the patient ever presented symptoms like rash, blood in stool, vomiting, difficulty breathing, strong headache, stomach ache or fever the patient should go back to the hospital.The patient was prescribed with medication just for nausea.

• Brand Name: COREGA TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7906867
• MDR Text Key: 121712665
• Report Number: 1020379-2018-00060
• 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: 09/17/2018

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
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 09/25/2018
• 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