SYMMETRY SHARP KERRISON 53-1675

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 SYMMETRY SHARP KERRISON 53-1675 manufactured by Symmetry Surgical Inc.

MAUDE Entry Details

Report Number3007208013-2019-00004
MDR Report Key8676111
Date Received2019-06-06
Date of Report2019-01-13
Date of Event2019-01-17
Date Mfgr Received2019-01-17
Date Added to Maude2019-06-06
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 G1SYMMETRY SURGICAL
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 NameSYMMETRY SHARP KERRISON
Generic NameRONGEUR
Product CodeHAE
Date Received2019-06-06
Catalog Number53-1675
Lot Number1600651, 1500492
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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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