FDA.reportPublic FDA data

MAUDE MDR 9720741

MDR report key
9720741
Report number
3014276660-2020-20040
Event key
0
Event type
3
Date of event
2019-10-22
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 PLACE STE. 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
1SAALTREGULAR BLUESAALT, LLCHHEREGULAR BLUER N

Patients#

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

Event Narratives#

D

Patient 1

CUSTOMER USED CUP FOR THE FIRST TIME AND EASILY REMOVED IT AFTER AN HOUR. CUSTOMER REINSERTED HER CUP THEN ATTEMPTED REMOVAL FOR A SECOND TIME 5 HOURS LATER. AFTER UTILIZING MULTIPLE SAALT RESOURCES AS WELL AS OTHER WEBSITES AND (B)(6) CHANNELS, CUSTOMER STILL COULD NOT REACH AND REMOVE HER CUP. CUSTOMER ATTEMPTED REMOVAL FOR 3 HOURS PRIOR TO GOING TO URGENT CARE. CUSTOMER SAYS SHE COULD ONLY BEAR THE CUP DOWN ENOUGH TO REACH THE TIP OF THE STEM. THE DOCTOR REMOVED HER CUP AND RETURNED THE CUP TO THE CUSTOMER. SAALT FOLLOWED UP WITH ADDITIONAL REMOVAL RESOURCES AND OFFERED A REFUND FOR THE PURCHASE OF THE CUP.