FDA.reportPublic FDA data

MAUDE MDR 8498997

MDR report key
8498997
Report number
1020379-2019-00021
Event key
0
Event type
3
Date of event
2019-03-29
Date received
2019-04-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
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 OVERNIGHT DENTURE CLEANSER TABLETSDENTURE CLEANSERBLOCK DRUG CO., INC.EFTUNKR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1001. O

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

MY WIFE TOOK A SWALLOW OF THE SOLUTION. I USE THE SOLUTION BUT SHE WOKE UP 4AM AND DRANK SOLUTION. [ACCIDENTAL DEVICE INGESTION]. LITTLE IRRITATION ON HER THROAT [THROAT IRRITATION]. THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON (B)(6) 2019, AN UNKNOWN TIME AFTER STARTING POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND THROAT IRRITATION. THE ACTION TAKEN WITH POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WAS UNKNOWN. ON (B)(6) 2019, THE OUTCOME OF THE THROAT IRRITATION WAS RECOVERED/RESOLVED. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND THROAT IRRITATION TO BE RELATED TO POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ADDITIONAL INFORMATION, ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON (B)(6) 2019. THE PATIENT HUSBAND CALLED AND REPORTED THAT, "MY WIFE TOOK A SWALLOW OF THE SOLUTION. I USE THE SOLUTION BUT SHE WOKE UP 4AM AND DRANK SOLUTION. ARE THERE ANY BAD SIDE EFFECTS? SHE IS OKAY BUT JUST A LITTLE IRRITATION ON HER THROAT."