FDA.reportPublic FDA data

MAUDE MDR 8590500

MDR report key
8590500
Report number
1020379-2019-00025
Event key
0
Event type
3
Date of event
2019-03-27
Date received
2019-05-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
PO BOX 13398 RESEARCH TRIANGLE PARK NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POLIDENT ACTIVE OXYGENDENTURE CLEANSERBLOCK DRUG CO., INC.EFTKE3CR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-0801. O

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

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 (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT ACTIVE OXYGEN) TABLET (BATCH NUMBER KE3C, EXPIRY DATE 30TH SEPTEMBER 2021) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT ACTIVE OXYGEN. ON (B)(6) 2019, AN UNKNOWN TIME AFTER STARTING POLIDENT ACTIVE OXYGEN, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH POLIDENT ACTIVE OXYGEN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT ACTIVE OXYGEN. ADDITIONAL DETAILS: A CONSUMER CALLED ON BEHALF OF HIS WIFE. THE PATIENT HAD INGESTED A TABLET OF POLIDENT BY ACCIDENT IN THE MORNING OF (B)(6) 2019. THEY HAD ALREADY CONTACTED THE ANTI-POISONS INFORMATION CENTRE AND THEIR PHYSICIAN AND WERE INFORMED TO INGEST PLENTY OF MILK, WATER, JUICES AND LIQUIDS.