FDA.reportPublic FDA data

MAUDE MDR 9263102

MDR report key
9263102
Report number
0002936485-2019-00493
Event key
0
Event type
3
Date of event
2019-10-22
Date received
2019-10-31
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
MR. CHESTER REBUGIO
Address
5900 OPTICAL COURT SAN JOSE CA 95138 US
Phone
408-408-4087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATORINSUFFLATOR, LAPAROSCOPICSTRYKER ENDOSCOPY-SAN JOSEHIF0620040610N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-3101. O

Event Narratives#

No narrative records found.