FDA.reportPublic FDA data

MAUDE MDR 9728187

MDR report key
9728187
Report number
1226348-2020-00006
Event key
0
Event type
3
Date of event
2020-01-28
Date received
2020-02-19
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
MR. GABRIEL ALFAGEME
Address
31 TECHNOLOGY DRIVE IRVINE CA 92618 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROWLER SELECT LPES 45 DEG TIPCATHETER, CONTINUOUS FLUSHCODMAN AND SHURTLEFF, INCKRA606-S155FX606S155FX30140219Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-190

Event Narratives#

No narrative records found.