PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG PRB35-06-120-120

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 2020-03-30 for PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG PRB35-06-120-120 manufactured by Covidien.

MAUDE Entry Details

Report Number2183870-2020-00092
MDR Report Key9897431
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-25
Date Mfgr Received2020-03-26
Device Manufacturer Date2018-04-12
Date Added to Maude2020-03-30
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 ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Manufacturer Phone091708734
Manufacturer G1COVIDIEN
Manufacturer Street4600 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeFGE
Date Received2020-03-30
Model NumberPRB35-06-120-120
Catalog NumberPRB35-06-120-120
Lot NumberA628708
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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