FDA.reportPublic FDA data

MAUDE MDR 9118744

MDR report key
9118744
Report number
9616099-2019-03224
Event key
0
Event type
3
Date of event
2019-07-29
Date received
2019-09-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARLA CASTRO
Address
14201 NW 60TH AVE MIAMI LAKES FL 33014 US
Phone
786-786-7863
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OUTBACK ELITE 120CM RE-ENTRYCATHETER FOR CROSSING TOTAL OCCLUSIONSCORDIS CORPORATIONPDUOTB59120AOTB59120A17833170R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-250

Event Narratives#

No narrative records found.