FDA.reportPublic FDA data

MAUDE MDR 8746282

MDR report key
8746282
Report number
8021764-2019-00012
Event key
0
Event type
3
Date of event
2019-05-15
Date received
2019-06-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. PATTY CRONAN
Address
1755 WEST OAK COMMONS CT. MARIETTA GA 30062 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNISTIK 2LANCETSOWEN MUMFORD LIMITEDFMKAT 0702R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-280

Event Narratives#

No narrative records found.