MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS C650-129A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-06-18 for MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS C650-129A manufactured by Gyrus Acmi, Inc.

MAUDE Entry Details

Report Number2951238-2019-00955
MDR Report Key8708469
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-06-18
Date of Report2019-06-18
Date of Event2019-05-17
Date Mfgr Received2019-05-20
Date Added to Maude2019-06-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
Generic NameMONOPOLAR ACTIVE CORD
Product CodeFAS
Date Received2019-06-18
Model NumberC650-129A
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer Address136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-18

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