SYMMETRY 63-4031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-11 for SYMMETRY 63-4031 manufactured by Symmetry Surgical, Inc.

MAUDE Entry Details

Report Number3007208013-2020-00004
MDR Report Key9695914
Report SourceUSER FACILITY
Date Received2020-02-11
Date of Report2020-02-11
Date of Event2020-01-08
Date Mfgr Received2020-01-15
Device Manufacturer Date2016-02-05
Date Added to Maude2020-02-11
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 ContactBRANDI MEATH
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH, TN
Manufacturer CountryUS
Manufacturer Phone9645290
Manufacturer G1SYMMETRY SURGICAL INC
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH, TN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYMMETRY
Generic NameVEIN STRIPPER
Product CodeGAJ
Date Received2020-02-11
Catalog Number63-4031
Lot Number228469
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSYMMETRY SURGICAL, INC
Manufacturer Address3034 OWEN DRIVE ANTIOCH, TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-11

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