FDA.reportPublic FDA data

MAUDE MDR 9644669

MDR report key
9644669
Report number
3014276660-2020-20004
Event key
0
Event type
3
Date of event
2018-12-21
Date received
2020-01-29
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 ID 83713 US
Phone
801-801-8013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAALTREGULARSAALTHHEREGULARR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2901. R

Event Narratives#

D

Patient 1

CUSTOMER REACHED OUT TO US ON 12/21/2018 LETTING US KNOW SHE INSERTED HER CUP COMFORTABLY AND WORE IT WHILE SLEEPING. ONCE IT WAS TIME TO REMOVE THE CUP IN THE MORNING, SHE WAS UNABLE TO REACH THE BASE OF THE CUP FOR REMOVAL. SHE TRIED FOR MANY HOURS TO REMOVE THE CUP WITHOUT SUCCESS. SHE ENDED UP VISITING HER LOCAL DOCTOR AND THE CUP WAS REMOVED BY A MEDICAL PROFESSIONAL. THE CUP WAS INSERTED FOR A TOTAL OF 19 HOURS AND SHE REPORTED RETURNING TO THE DOCTOR AT A LATER DATE DUE TO AN INFECTION SHE BELIEVES WAS CAUSED BY HER REMOVAL ATTEMPTS. SAALT HAS FOLLOWED UP TO ATTEMPT TO GAIN MORE INFORMATION AND REFUND THE CUSTOMER WITHOUT ANY RESPONSE.