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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

1020379-2018-00077 is associated with argus case (b)(4), corega tablets.Corega tablets is marketed in the us as polident denture cleaning tablets.

Event Description

Accidental ingestion [accidental device ingestion].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 product used 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).The action taken with corega tablets was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tablets.Additional details: the reporter stated that consumer (gender and age not specified) by accident ingested the effervescent drink of corega.

Manufacturer Narrative

Initial report is associated with argus case (b)(4), corega tablets.Corega tablets is marketed in the us as polident denture cleaning tablets.Follow up in response to fda request on 04 january 2019, provided supplement report translating the sentence which is in spanish language into english.

Event Description

Accidental ingestion [accidental device ingestion].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 product used 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).The action taken with corega tablets was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details; the reporter stated that consumer (gender and age not specified) by accident ingested the effervescent drink of corega.English translation (spanish reporters comment): "hello, is that by accident i ingested a little of the effervescent drink of corega".Spanish text; "hola, es que ingeri accidentalmente un poco de la bebida efervescente de corega".

• Brand Name: COREGA TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC; memphis TN
• MDR Report Key: 8213644
• MDR Text Key: 132579785
• Report Number: 1020379-2018-00077
• 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: 12/21/2018

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
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other