CUTTING ELECTRODE 8416.0305

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 2019-09-19 for CUTTING ELECTRODE 8416.0305 manufactured by Richard Wolf Medical Instruments Corp..

MAUDE Entry Details

Report Number1418479-2019-00050
MDR Report Key9090336
Report SourceUSER FACILITY
Date Received2019-09-19
Date of Report2019-08-29
Date Mfgr Received2019-08-19
Date Added to Maude2019-09-19
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 ContactMS. DAISY RAMOS
Manufacturer Street353 CORPORATE WOODS PARKWAY
Manufacturer CityVERNON HILLS IL 600613110
Manufacturer CountryUS
Manufacturer Postal600613110
Manufacturer Phone8479131113
Manufacturer G1RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Manufacturer Street353 CORPORATE WOODS PARKWAY
Manufacturer CityVERNON HILLS IL 600613110
Manufacturer CountryUS
Manufacturer Postal Code600613110
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCUTTING ELECTRODE
Generic NameCUTTING ELECTRODE
Product CodeFAS
Date Received2019-09-19
Model Number8416.0305
Catalog Number8416.0305
Lot Number1390827
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRICHARD WOLF MEDICAL INSTRUMENTS CORP.
Manufacturer Address353 CORPORATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-19

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