MAUDE MDR 9075467

MDR report key
9075467
Report number
1823260-2019-03319
Event key
0
Event type
3
Date of event
2019-07-02
Date received
2019-09-17
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
1CREJ2 CREATININE JAFF? GEN.2ALKALINE PICRATE, COLORIMETRY, CREATININEROCHE DIAGNOSTICSCGXCREAJ06407137190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-170

Event Narratives#

No narrative records found.