FDA.reportPublic FDA data

MAUDE MDR 9182859

MDR report key
9182859
Report number
8021764-2019-00014
Event key
0
Event type
3
Date of event
2019-09-10
Date received
2019-10-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1UNIFINE PENTIPS PLUSPEN NEEDLEOWEN MUMFORD LIMITEDFMIAN 383018P4001.V876R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-1101. O

Event Narratives#

No narrative records found.