COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER FFCM3205

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-10-21 for COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER FFCM3205 manufactured by Corometrics Medical Systems, Inc..

MAUDE Entry Details

Report Number3007409280-2019-00054
MDR Report Key9215798
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2019-10-21
Date of Report2019-09-30
Date Mfgr Received2019-09-30
Date Added to Maude2019-10-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJENNA VARGAS
Manufacturer Street212 AVENIDA FABRICANTE
Manufacturer CitySAN CLEMENTE CA 92672
Manufacturer CountryUS
Manufacturer Postal92672
Manufacturer G1AVANTE HEALTH SOLUTIONS
Manufacturer Street212 AVENIDA FABRICANTE
Manufacturer CitySAN CLEMENTE CA 92672
Manufacturer CountryUS
Manufacturer Postal Code92672
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
Generic NameTRANSDUCER
Product CodeHEL
Date Received2019-10-21
Returned To Mfg2019-09-06
Model NumberFFCM3205
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOROMETRICS MEDICAL SYSTEMS, INC.
Manufacturer Address61 BARNES PARK RD. NORTH WALLINGFORD CT 06492 US 06492


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-21

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