RD DEPTH ELECTRODE RD10R-SP04X-000

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 2020-02-13 for RD DEPTH ELECTRODE RD10R-SP04X-000 manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[187944981] Mdr 2183456-2020-00011 has been filed past the 30-day timeframe. Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur. As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Patient Sequence No: 1, Text Type: N, H10


[187944982] On september 19, 2017 ad-tech received a complaint of a bent electrode prior to clinical use. There was no report of patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183456-2020-00011
MDR Report Key9707522
Report SourceOTHER
Date Received2020-02-13
Date of Report2020-02-13
Date of Event2017-09-18
Date Mfgr Received2017-09-19
Device Manufacturer Date2017-06-15
Date Added to Maude2020-02-13
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 ContactMISS NICOLE REMER
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK, WI
Manufacturer CountryUS
Manufacturer Phone6341555301
Manufacturer G1AD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK, WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRD DEPTH ELECTRODE
Generic NameDEPTH ELECTRODE
Product CodeGZL
Date Received2020-02-13
Returned To Mfg2017-10-03
Model NumberRD10R-SP04X-000
Catalog NumberRD10R-SP04X-000
Lot Number208140645
Device Expiration Date2019-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Address400 WEST OAKVIEW PARKWAY OAK CREEK, WI US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-13

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