FDA.reportPublic FDA data

MAUDE MDR 9720750

MDR report key
9720750
Report number
3014276660-2020-20042
Event key
0
Event type
3
Date of event
2019-10-29
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
1SAALTSMALL BLUESAALT, LLCHHESMALL BLUER N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-180

Event Narratives#

D

Patient 1

CUSTOMER HAD USED HER SAALT CUP FOR 4 PERIODS BEFORE THE STEM BROKE OFF DURING REMOVAL ON (B)(6) 2019. CUSTOMER WENT TO URGENT CARE TO HAVE CUP REMOVED AS SHE COULD NOT REACH THE BASE OF THE CUP WITHOUT USING THE STEM TO REMOVE THE CUP. THE DOCTOR DISGARDED THE CUP AT THE HOSPITAL. SAALT PROVIDED A REFUND FOR THE PURCHASE OF THE CUP AND REMOVAL TIPS IF SHE CHOOSES TO USE A MENSTRUAL CUP IN THE FUTURE.