FDA.reportPublic FDA data

MAUDE MDR 9787821

MDR report key
9787821
Report number
3006260740-2020-00715
Event key
0
Event type
3
Date of event
2020-02-10
Date received
2020-03-04
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
KELSEY ERICKSON
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
13FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVERMIDLINE CATHETERBARD ACCESS SYSTEMSPNDN/AS4153108BDPREDR2840N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-040

Event Narratives#

No narrative records found.