COPILOT BLEEDBACK CONTROL VALVE 1003331

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 2019-07-03 for COPILOT BLEEDBACK CONTROL VALVE 1003331 manufactured by Av-temecula-ct.

MAUDE Entry Details

Report Number2024168-2019-05380
MDR Report Key8759611
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-03
Date of Report2019-07-03
Date of Event2018-12-01
Date Mfgr Received2019-06-13
Date Added to Maude2019-07-03
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 ContactCONNIE SPECK
Manufacturer StreetABBOTT VASCULAR 26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
Manufacturer StreetABBOTT VASCULAR 26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOPILOT BLEEDBACK CONTROL VALVE
Generic NameHEMOSTATIC VALVE
Product CodeDTL
Date Received2019-07-03
Catalog Number1003331
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAV-TEMECULA-CT
Manufacturer AddressABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-03

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