CHATTANOOGA INTCB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-03-23 for CHATTANOOGA INTCB manufactured by Djo, Llc.

Event Text Entries

[5593160] Per 21cfr part 803, an mdr reportable event. Lawsuit received from that alleges "patient began to feel an intense and hot burning sensation coming from the electrodes(s) connected to his upper left trapezius and to the intelect legend unit, resulting in a third degree burn directly underneath the electrode on the upper left trapezius and in significant electrical trauma and injury to his entire body, including but not limited to, his trapezius, brain, peripheral nervous system and left eye". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2015-00004
MDR Report Key4627405
Report Source00
Date Received2015-03-23
Date of Report2015-03-13
Date of Event2014-04-18
Date Added to Maude2015-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1430 DECISION ST
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer Phone7607271280
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHATTANOOGA
Generic NameINTELECT LEGEND
Product CodeIMI
Date Received2015-03-23
Model NumberINTCB
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-03-23

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