SITUATE G0404-16P01C-1

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 2019-11-22 for SITUATE G0404-16P01C-1 manufactured by Mitg - Rf Surgical Systems.

MAUDE Entry Details

Report Number3005883396-2019-00102
MDR Report Key9364692
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-22
Date of Report2019-11-22
Date of Event2019-11-06
Date Mfgr Received2019-11-06
Date Added to Maude2019-11-22
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 ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1MITG - RF SURGICAL SYSTEMS
Manufacturer Street2101 FARADAY
Manufacturer CityCARLSBAD CA 92008
Manufacturer CountryUS
Manufacturer Postal Code92008
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSITUATE
Generic NameGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Product CodeGDY
Date Received2019-11-22
Model NumberG0404-16P01C-1
Catalog NumberG0404-16P01C-1
Lot Number190302AF
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMITG - RF SURGICAL SYSTEMS
Manufacturer Address2101 FARADAY CARLSBAD CA 92008 US 92008


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-22

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