FDA.reportPublic FDA data

MAUDE MDR 9720789

MDR report key
9720789
Report number
3014276660-2020-20057
Event key
0
Event type
3
Date of event
2020-01-13
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 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 GREYSAALT, LLCHHESMALL GREYN/AN/AN N

Patients#

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

Event Narratives#

D

Patient 1

CUSTOMER CONTACTED SAALT ON (B)(6) 2020 TO NOTIFY SAALT THAT SHE WENT TO THE DOCTOR TO HAVE HER CUP REMOVED. SHE ATTEMPTED TO REMOVE HER CUP AFTER 6 HOURS OF WEAR, AND THEN CHOSE TO SEEK MEDICAL CARE AFTER HAVING THE CUP INSERTED FOR 36 HOURS. SAALT RESPONDED AND PROVIDED REMOVAL TECHNIQUES AND A REPLACEMENT CUP.