ROSA BRAIN ROSA BRAIN 3.0 ROSAS00303

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 2019-11-29 for ROSA BRAIN ROSA BRAIN 3.0 ROSAS00303 manufactured by Medtech Sa.

MAUDE Entry Details

Report Number3009185973-2019-00424
MDR Report Key9391801
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-08-20
Date Mfgr Received2019-08-20
Device Manufacturer Date2018-06-05
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JAY SHARMA
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1MEDTECH SA
Manufacturer StreetZAC EUREKA 900 RUE DU MAS DE VERCHANT
Manufacturer CityMONTPELLIER, LANGUEDOC-ROUSSILLON 34000
Manufacturer CountryFR
Manufacturer Postal Code34000
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameROSA BRAIN
Generic NameCOMPUTER-ASSISTED SURGICAL DEVICE
Product CodeHAW
Date Received2019-11-29
Model NumberROSA BRAIN 3.0
Catalog NumberROSAS00303
Lot Number3.0.0.20
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDTECH SA
Manufacturer AddressZAC EUREKA 900 RUE DU MAS DE VERCHANT MONTPELLIER, LANGUEDOC-ROUSSILLON 34000 FR 34000


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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