FDA.reportPublic FDA data

MAUDE MDR 9119341

MDR report key
9119341
Report number
1917413-2019-02128
Event key
0
Event type
3
Date of event
2019-09-10
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
BDX BRETT WILKO
Address
9450 SOUTH STATE STREET SANDY UT 84070 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BD KIT URIN CUP PLC 16X100 10.0 UA YELURINE COLLECTION DEVICEBECTON, DICKINSON & CO. (BROKEN BOW)JTW364981UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-2501. O

Event Narratives#

No narrative records found.