YUNO 2 EU WITH AUTODRIVE 143302B0

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 2019-10-15 for YUNO 2 EU WITH AUTODRIVE 143302B0 manufactured by Holger Ullrich.

MAUDE Entry Details

Report Number8010652-2019-00025
MDR Report Key9189943
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-15
Date of Report2019-10-31
Date of Event2019-10-05
Date Mfgr Received2019-10-09
Device Manufacturer Date2018-11-08
Date Added to Maude2019-10-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetMAQUET GMBH KEHLER STRASSE 31,
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal76437
Manufacturer G1HOLGER ULLRICH
Manufacturer StreetMAQUET GMBH KEHLER STRASSE 31,
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal Code76437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameYUNO 2 EU WITH AUTODRIVE
Generic NameTABLE, OPERATING-ROOM, AC-POWERED
Product CodeFQO
Date Received2019-10-15
Model Number143302B0
Catalog Number143302B0
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLGER ULLRICH
Manufacturer AddressMAQUET GMBH KEHLER STRASSE 31, RASTATT 76437 GM 76437


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-10-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.