CHATTANOOGA 2761

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-05 for CHATTANOOGA 2761 manufactured by Djo, Llc.

Event Text Entries

[16687164] Complaint received from clinic that alleges "patient received third degree burns during stim treatment. " product not received by manufacturer for review. Product questionnaire not received from clinician and/or patient. Complaint alleges event caused or contributed to permanent impairment, injury or death. Complaint alleges device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2014-00003
MDR Report Key3631966
Report Source05
Date Received2014-02-05
Date of Report2014-02-03
Date Added to Maude2014-02-20
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 Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHATTANOOGA
Generic NameVECTRA GENISYS 2CH COMBO PKG
Product CodeGZI
Date Received2014-02-05
Model Number2761
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST. VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-02-05

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