FDA.reportPublic FDA data

MAUDE MDR 9742249

MDR report key
9742249
Report number
8030229-2020-00089
Event key
0
Event type
3
Date of event
2020-01-22
Date received
2020-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SHAMA MOOMAN
Address
SAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2 KUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8 JA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORG-9110AMULTIPLE PATIENT RECEIVERNIHON KOHDEN CORPORATIONDRGORG-9110AORG-9110ANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-210

Event Narratives#

No narrative records found.