FDA.reportPublic FDA data

MAUDE MDR 8920163

MDR report key
8920163
Report number
2134265-2019-09695
Event key
0
Event type
3
Date of event
2019-07-26
Date received
2019-08-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EXPRESS SD RENAL/BILIARYCATHETER, BILIARY, DIAGNOSTICBOSTON SCIENTIFIC CORPORATIONNIN20188201880022574558R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-2201. O

Event Narratives#

No narrative records found.