FDA.reportPublic FDA data

MAUDE MDR 9595908

MDR report key
9595908
Report number
1221934-2020-00224
Event key
0
Event type
3
Date of event
2019-12-17
Date received
2020-01-16
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
KARA DITTY-BOVARD
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1242326EVOLUTION4KDEPUY MITEK LLC USFCWEvo4K220242326R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-160

Event Narratives#

No narrative records found.