FDA.reportPublic FDA data

MAUDE MDR 8700183

MDR report key
8700183
Report number
3010692967-2019-00018
Event key
0
Event type
3
Date of event
2019-05-09
Date received
2019-06-14
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
MR. RONALD GIANNANGELO
Address
247 STATION DRIVE SUITE NE1 WESTWOOD MA 02090 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STRATAFIXMONODERMSURGICAL SPECIALTIES CORPORATIONGABSXMD1B102MDVR550N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-140

Event Narratives#

No narrative records found.