FDA.reportPublic FDA data

MAUDE MDR 8914589

MDR report key
8914589
Report number
1823260-2019-03055
Event key
0
Event type
3
Date of event
2019-07-23
Date received
2019-08-21
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
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ECOTERGENTGENERAL PURPOSE REAGENTROCHE DIAGNOSTICSPPMECOTERGENT07734522001ASKUR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-2101. O

Event Narratives#

No narrative records found.