FDA.reportPublic FDA data

MAUDE MDR 9158903

MDR report key
9158903
Report number
8021764-2019-00013
Event key
0
Event type
3
Date of event
2019-08-09
Date received
2019-10-04
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 3 DUALSAFETY LANCETOWEN MUMFORD LIMITEDFMKAT 1064033795Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-0401. O

Event Narratives#

No narrative records found.