AXCEL ARD567501985

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-29 for AXCEL ARD567501985 manufactured by Maquet Sas.

MAUDE Entry Details

Report Number9710055-2019-00341
MDR Report Key9391598
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date Mfgr Received2019-11-26
Date Added to Maude2019-11-29
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 ContactMR. PASCAL JAY
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Manufacturer G1MAQUET SAS
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXCEL
Generic NameLIGHT, SURGICAL, CEILING MOUNTED
Product CodeFSY
Date Received2019-11-29
Model NumberARD567501985
Catalog NumberARD567501985
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET SAS
Manufacturer AddressPARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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