RD DEPTH ELECTRODE RD10R-SP07X-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-29 for RD DEPTH ELECTRODE RD10R-SP07X-000 manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[185089978] Mdr 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 year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Patient Sequence No: 1, Text Type: N, H10


[185089979] On (b)(6) 2018 ad-tech received a complaint of a stylet which had punctured through the bottom of an electrode prior to clinical use. There was no report of patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183456-2020-00001
MDR Report Key9644690
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-29
Date of Report2020-01-29
Date of Event2018-08-15
Date Mfgr Received2018-08-22
Date Added to Maude2020-01-29
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. PAMELA STOGSDILL
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK WI 53154
Manufacturer CountryUS
Manufacturer Postal53154
Manufacturer Phone2626341555
Manufacturer G1AD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK WI 53154
Manufacturer CountryUS
Manufacturer Postal Code53154
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRD DEPTH ELECTRODE
Generic NameDEPTH ELECTRODE
Product CodeGZL
Date Received2020-01-29
Returned To Mfg2018-08-24
Model NumberRD10R-SP07X-000
Catalog NumberRD10R-SP07X-000
Lot Number208140640
Device Expiration Date2019-04-01
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 53154 US 53154


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-29

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