FDA.reportPublic FDA data

MAUDE MDR 9720689

MDR report key
9720689
Report number
3014276660-2020-20015
Event key
0
Event type
3
Date of event
2019-05-20
Date received
2020-02-18
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#

Contact
DANIELLE BURDEN
Address
6149 N MEEKER PL SUITE 110 BOISE ID 83713 US
Phone
801-801-8013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAALT CUPDUO PACKSAALT, LLCHHEREGULAR BLUE - DUO PACKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1801. R

Event Narratives#

D

Patient 1

THE CUSTOMER CONTACTED SAALT AFTER HAVING VISITED THE URGENT CARE TO HAVE HER CUP REMOVED. AFTER ADDITIONAL CONTACT, THE CUSTOMER NOTED THAT THIS WAS HER FIRST CYCLE AND SHE HAD USED THE SMALL CUP WITH SUCCESS SEVERAL TIMES. ON THIS PARTICULAR OCCASION THE CUSTOMER INSERTED THE REGULAR SIZE CUP PRIOR TO GOING TO BED. IN THE MORNING SHE TRIED MANY DIFFERENT METHODS TO REMOVE THE DEVICE, INCLUDING INSERTING A SPOON TO ATTEMPT TO REMOVE THE CUP. SHE WAITED A COUPLE OF HOURS BEFORE TRYING AGAIN. WHEN SHE WASN'T ABLE TO REMOVE THE DEVICE AT THAT TIME SHE DECIDED TO GO TO URGENT CARE WHERE THE DOCTOR WAS ABLE TO GET IT OUT. THE CUSTOMER STATED THAT THE DOCTOR NOTED THAT HER CERVIX IS QUITE HIGH, WHICH MADE THE CUP DIFFICULT TO REACH.