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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Accidental ingestion [accidental device ingestion].Induced vomiting [self-induced vomiting].Abdominal pain [abdominal pain].Case description: this case was reported by a consumer via out of hour services and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (corega tabs) unknown for denture wearer.Co-suspect products included aspirin, sodium carbonate, sodium bicarbonate, citric acid (sonrisal) unknown for product used for unknown indication.On an unknown date, the patient started corega tabs and sonrisal at an unknown dose and frequency.On (b)(6) 2016, an unknown time after starting corega tabs and sonrisal, the patient experienced accidental device ingestion (serious criteria gsk medically significant), self-induced vomiting, abdominal pain, wrong drug administered and medication error.The action taken with sonrisal was unknown.On (b)(6) 2016, the outcome of the accidental device ingestion, self-induced vomiting, wrong drug administered and medication error were recovered/resolved.On an unknown date, the outcome of the abdominal pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, self-induced vomiting and abdominal pain to be related to corega tabs.It was unknown if the reporter considered the accidental device ingestion to be related to sonrisal.Additional information: the patient reportedly confused corega with sonrisal and drank 1 tab of corega with water and brown sugar in the night on (b)(6) 2016.When she noticed the taste she induced vomit and ate papaya with oats.

• Brand Name: COREGA TABS
• 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: 6019977
• MDR Text Key: 57053810
• Report Number: 1020379-2016-00047
• 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: 10/02/2016

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: No Information
• Initial Date Manufacturer Received: 10/02/2016
• Initial Date FDA Received: 10/12/2016
• 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: 46 YR