RAPIDVAC SE3695

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-11-04 for RAPIDVAC SE3695 manufactured by Covidien Mfg Dc Boulder.

MAUDE Entry Details

Report Number1717344-2019-01457
MDR Report Key9276373
Report SourceFOREIGN,USER FACILITY
Date Received2019-11-04
Date of Report2019-11-04
Date of Event2019-10-02
Date Mfgr Received2019-10-18
Device Manufacturer Date2014-03-31
Date Added to Maude2019-11-04
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 ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MFG DC BOULDER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 803013299
Manufacturer CountryUS
Manufacturer Postal Code803013299
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPIDVAC
Generic NameAPPARATUS, EXHAUST, SURGICAL
Product CodeFYD
Date Received2019-11-04
Model NumberSE3695
Catalog NumberSE3695
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG DC BOULDER
Manufacturer Address5920 LONGBOW DRIVE BOULDER CO 803013299 US 803013299


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-04

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