SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-06-14 for SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS manufactured by Ad-tech Medical Instrument Corp..

MAUDE Entry Details

Report Number2183456-2019-00004
MDR Report Key8701820
Report SourceOTHER
Date Received2019-06-14
Date of Report2019-06-14
Date Mfgr Received2019-05-31
Date Added to Maude2019-06-14
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 ContactMRS. KATHLEEN BARLOW
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK 53154
Manufacturer CountryUS
Manufacturer Postal53154
Manufacturer Phone2626341555
Manufacturer G1AD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK 53154
Manufacturer CountryUS
Manufacturer Postal Code53154
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
Generic NameSUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
Product CodeGZL
Date Received2019-06-14
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Address400 WEST OAKVIEW PARKWAY OAK CREEK 53154 US 53154


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.