ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE ECHO-19

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-26 for ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE ECHO-19 manufactured by Cook Ireland Ltd.

MAUDE Entry Details

Report Number3001845648-2020-00122
MDR Report Key9754962
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-26
Date of Report2020-01-29
Date of Event2019-10-30
Date Facility Aware2019-10-30
Date Mfgr Received2020-02-03
Device Manufacturer Date2017-11-15
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. HEATHER RYAN
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Manufacturer Phone061334440
Manufacturer G1COOK IRELAND LTD
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Generic NameFCG KIT, NEEDLE, BIOPSY
Product CodeFCG
Date Received2020-02-26
Returned To Mfg2020-02-18
Catalog NumberECHO-19
Lot NumberC1422374
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age714 DA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK IRELAND LTD
Manufacturer AddressO HALLORAN ROAD LIMERICK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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