BLUELINE HM56077460

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for BLUELINE HM56077460 manufactured by Maquet Sas.

MAUDE Entry Details

Report Number9710055-2019-00273
MDR Report Key9103794
Date Received2019-09-23
Date of Report2019-11-15
Date of Event2019-09-18
Date Mfgr Received2019-10-24
Date Added to Maude2019-09-23
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 StreetPARC DE LIM AVENUE DE LA POMME DE PI
Manufacturer CityORL 45074
Manufacturer CountryFR
Manufacturer Postal45074
Manufacturer Phone0332382587
Manufacturer G1PASCAL JAY - MAQUET SAS
Manufacturer StreetPARC DE LIM AVENUE DE LA POMME DE PI
Manufacturer CityORL 45074
Manufacturer CountryFR
Manufacturer Postal Code45074
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLUELINE
Generic NameLIGHT, SURGICAL, FLOOR STANDING
Product CodeFSS
Date Received2019-09-23
Catalog NumberHM56077460
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2019-09-23

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