FDA.reportPublic FDA data

MAUDE MDR 8649390

MDR report key
8649390
Report number
1020379-2019-00030
Event key
0
Event type
3
Date received
2019-05-29
Adverse event
3
Product problem
0
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
1COREGA TABS 3 MINUTENDENTURE CLEANSERBLOCK DRUG CO., INC.EFTMH071524AR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-2901. O

Event Narratives#

N

Patient 1

ARGUS CASE (B)(4).

D

Patient 1

BREAST CANCER. LEFT DENTURE IN A GLASS WITH EXPIRED PRODUCT (EXPIRED DEVICE USED). LEFT DENTURE IN A GLASS WITH EXPIRED PRODUCT (WRONG TECHNIQUE IN DEVICE USAGE PROCESS). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BREAST CANCER IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED DENTURE CLEANSER (COREGA TABS 3 MINUTEN) TABLET (BATCH NUMBER MH071524A, EXPIRY DATE 31ST AUGUST 2017) FOR DRUG USE FOR UNKNOWN INDICATION. IN 2016, THE PATIENT STARTED COREGA TABS 3 MINUTEN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA TABS 3 MINUTEN, THE PATIENT EXPERIENCED BREAST CANCER (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), EXPIRED DEVICE USED AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS. THE ACTION TAKEN WITH COREGA TABS 3 MINUTEN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE BREAST CANCER, EXPIRED DEVICE USED AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BREAST CANCER, EXPIRED DEVICE USED AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS TO BE RELATED TO COREGA TABS 3 MINUTEN. (B)(4). ADDITIONAL DETAILS: CONSUMER WAS A BUYER OF COREGA TABLETS AND THE THING WAS THAT SHE WENT THROUGH A LONG PROCESS OF AN ILLNESS AND SHE HAD BOUGHT A BOX OF COREGA TABLETS AND IT EXPIRED IN 2017. IT WAS 23 TABLETS. ON REPORTING DAY SHE PUTTED THE DENTURE IN WITH THE PRODUCT. SHE BOUGHT THEM, BUT THEN SHE LEFT THEM BECAUSE SHE HAD AN ILLNESS, BREAST CANCER. SHE WOULD TAKE OUT HER DENTURE, SHE DID NOT BECAUSE SHE WANTED TO BUY SOMETHING. SHE WANTED TO HAVE A CLEANER DENTURE BUT SHE WAS RETIRED. SHE WAS GOING TO PUT IT IN A GLASS AND SEE WHAT HAPPENED BUT NOW SHE WAS SCARED THAT THERE COULD BE A CONTRAINDICATION WHEN SHE PUTTED HER DENTURES ON. NEXT MONTH SHE HAD SURGERY DONE FOR A MALPRAXIS. THE CONSUMER MENTIONED THAT SHE STARTED TO USE COREGA TABLETS IN 2016 AND AT THE SAME TIME, THAT YEAR, SHE STOPPED USING THEM DUE TO BREAST CANCER.