FDA.reportPublic FDA data

MAUDE MDR 9535802

MDR report key
9535802
Report number
3005778470-2019-00189
Event key
0
Event type
3
Date of event
2019-12-01
Date received
2019-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JEANETTE JOHNSON
Address
7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GENTLE CATHCATHETER, URETHRALUNOMEDICAL S.R.O.GBM4219118G00725N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-310

Event Narratives#

No narrative records found.