MAUDE Adverse Event Report: COREGA OXIGENO BIO-ACTIVO; DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), corega oxigeno bio-activo.Corega oxigeno bio-activo is marketed in the us as polident tablets.

Event Description

Product ingestion by mistake [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 (b)(6) male patient who received unknown salt denture cleanser (corega oxigeno bio-activo) tablet.For product used for unknown indication.On an unknown date, the patient started corega oxigeno bio-activo.On an unknown date, an unknown time after starting corega oxigeno bio-activo, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega oxigeno bio-activo.Additional information: the action taken with corega oxigeno bio-activo was not applicable.The patient ingested half a glass containing corega oxigeno bio activo.He presented no adverse event at the time of reporting.Spanish text: reporters comment: el paciente ingiere el producto por error.No presenta acontecimientos adversos.

• Brand Name: COREGA OXIGENO BIO-ACTIVO
• Type of Device: DENTURE CLEANSER
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7311579
• MDR Text Key: 101473780
• Report Number: 1020379-2018-00014
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• 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
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR