SYMMETRY SHARP KERRISON 53-1664

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-20 for SYMMETRY SHARP KERRISON 53-1664 manufactured by Symmetry Surgical Inc.

MAUDE Entry Details

Report Number3007208013-2019-00031
MDR Report Key8910886
Date Received2019-08-20
Date of Report2019-10-16
Date Mfgr Received2019-09-20
Date Added to Maude2019-08-20
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 ContactBRANDI MEATH
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH TN 37013
Manufacturer CountryUS
Manufacturer Postal37013
Manufacturer Phone6159645290
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 Report3

Device Details

Brand NameSYMMETRY SHARP KERRISON
Generic NameKERRISON RONGEUR
Product CodeHAE
Date Received2019-08-20
Returned To Mfg2019-09-20
Catalog Number53-1664
Lot Number19B438CT
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYMMETRY SURGICAL INC
Manufacturer Address3034 OWEN DRIVE ANTIOCH TN 37013 US 37013


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-20

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