FDA.reportPublic FDA data

MAUDE MDR 9645046

MDR report key
9645046
Report number
2210968-2020-00820
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-01-29
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
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STLESS STEEL SIL 4X18IN 7 S/A CCSSUTURE, NONABSORBABLE, STEELETHICON INC.GAQM655GM655GPKR595R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-290

Event Narratives#

No narrative records found.