FDA.reportPublic FDA data

MAUDE MDR 9848023

MDR report key
9848023
Report number
3001845648-2020-00158
Event key
0
Event type
3
Date of event
2020-02-17
Date received
2020-03-18
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
MS. HEATHER RYAN
Address
O HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLEFCG KIT, NEEDLE, BIOPSYCOOK IRELAND LTDFCGECHO-HD-22-EBUS-OC1665756Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1801. R

Event Narratives#

No narrative records found.