BOVIE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-06 for BOVIE manufactured by Symmetry Surgical Inc.

MAUDE Entry Details

Report Number3007208013-2019-00005
MDR Report Key8675994
Date Received2019-06-06
Date of Report2019-02-27
Date of Event2019-01-25
Date Mfgr Received2019-01-31
Device Manufacturer Date2017-12-11
Date Added to Maude2019-06-06
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 ContactBRANDI MEATH
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH TN 37013
Manufacturer CountryUS
Manufacturer Postal37013
Manufacturer G1SYMMETRY SURGICAL INC
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH TN 37013
Manufacturer CountryUS
Manufacturer Postal Code37013
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBOVIE
Generic NameCAUTERY HIGH TEMP
Product CodeHQP
Date Received2019-06-06
Lot Number1217E
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSYMMETRY SURGICAL INC
Manufacturer Address3034 OWEN DRIVE ANTIOCH TN 37013 US 37013


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-06

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