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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Vomiting (2144); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4) corega tabs dental weiss.Corega tabs dental weiss are marketed as polident in the us.

Event Description

Accidental ingestion [accidental device ingestion], craving for vomiting [nausea], 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 female patient who received denture cleanser (corega tabs dental weiss) tablet for denture wearer.On an unknown date, the patient started corega tabs dental weiss.On an unknown date, an unknown time after starting corega tabs dental weiss, the patient experienced accidental device ingestion (serious criteria gsk medically significant), nausea and vomiting.On an unknown date, the outcome of the accidental device ingestion was recovered/resolved and the outcome of the nausea and vomiting were not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs dental weiss.The reporter considered the nausea and vomiting to be related to corega tabs dental weiss.Additional details: the consumer reported that she and her son ingested corega tabs accidentally, because both confused with another medicament.She experienced craving for vomiting and vomiting.This product was contraindicated to ingestion.Her son did not experience any adverse event.Accidental device ingestion considered as medication error associated with adverse event.The reporter considered the accidental device ingestion to be unknown to corega tabs dental weiss.This case was linked with this (b)(4).

• Brand Name: COREGA TABS DENTAL WEISS
• 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: 7655881
• MDR Text Key: 112943078
• Report Number: 1020379-2018-00030
• 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: 06/21/2018

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: 06/21/2018
• Initial Date FDA Received: 07/02/2018
• 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