MAUDE MDR 9131177

MDR report key
9131177
Report number
8020790-2019-00056
Event key
0
Event type
3
Date received
2019-09-27
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
MS. JENNIFER ARMSTRONG
Address
595 ANGLUM ROAD HAZELWOOD MO 63042 US
Phone
314-314-3145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PREVI? COLOR GRAM INSTRUMENTPREVI? COLOR GRAM INSTRUMENTBIOMERIEUX SAKPA414292R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-270

Event Narratives#

No narrative records found.