3.5MM STERLING SPHERICAL BUR H9110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-28 for 3.5MM STERLING SPHERICAL BUR H9110 manufactured by Conmed Corporation.

MAUDE Entry Details

Report Number1017294-2019-00140
MDR Report Key9245565
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-28
Date of Report2019-10-28
Date of Event2019-10-04
Date Mfgr Received2019-10-07
Date Added to Maude2019-10-28
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 ContactMS TRACEY WEISELBENTON
Manufacturer Street11311 CONCEPT BLVD
Manufacturer CityLARGO FL 337734908
Manufacturer CountryUS
Manufacturer Postal337734908
Manufacturer Phone7273995557
Manufacturer G1CONMED CORPORATION
Manufacturer Street11311 CONCEPT BLVD
Manufacturer CityLARGO FL 337734908
Manufacturer CountryUS
Manufacturer Postal Code337734908
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3.5MM STERLING SPHERICAL BUR
Generic NameBUR, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGFF
Date Received2019-10-28
Catalog NumberH9110
Lot Number646771
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORPORATION
Manufacturer Address11311 CONCEPT BLVD LARGO FL 337734908 US 337734908


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-28

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