OJEMAN CORTICAL STIMULATOR OCS2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-03-25 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc.

Event Text Entries

[19795614] To date, the device involved in the reported incident has not be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


[19797929] The product was not stimulating. No other info was provided. Several attempts have been made to obtain info but to date, no new info has been received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222895-2014-00005
MDR Report Key3815919
Report Source01
Date Received2014-03-25
Date of Report2014-03-06
Date Mfgr Received2014-03-20
Date Added to Maude2014-06-13
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 FDA0
Event Location0
Manufacturer ContactROWENA BUNUAN
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOJEMAN CORTICAL STIMULATOR
Generic NameNA
Product CodeGYC
Date Received2014-03-25
Catalog NumberOCS2
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA BURLINGTON, MA, INC
Manufacturer AddressBURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-25

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