FDA.reportPublic FDA data

MAUDE MDR 9876151

MDR report key
9876151
Report number
3006260740-2020-00977
Event key
0
Event type
3
Date of event
2020-03-01
Date received
2020-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KAYLA OLSEN
Address
605 N. 5600 W. SALT LAKE CITY UT 84116 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCERCATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYSBARD ACCESS SYSTEMSLJSN/A7617405REDP0013R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-240

Event Narratives#

No narrative records found.