FDA.reportPublic FDA data

MAUDE MDR 9219293

MDR report key
9219293
Report number
2210968-2019-88925
Event key
0
Event type
3
Date received
2019-10-22
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
1PDS PLATE UNKNOWN PRODUCTPOLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLEETHICON INC.NHBR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-2201. R

Event Narratives#

No narrative records found.