MAUDE MDR 9088364

MDR report key
9088364
Report number
9612501-2019-01778
Event key
0
Event type
3
Date of event
2019-08-20
Date received
2019-09-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STEELSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILEDAVIS & GECK CARIBE LTDGAQ88862410-6988862410-69D9E1212Y* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-190

Event Narratives#

No narrative records found.