TRITON 4739

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-18 for TRITON 4739 manufactured by Djo, Llc.

Event Text Entries

[4685568] Complaint received from clinician that alleges "the unit keeps pulling after treatment". Questionnaire received from clinician stating no injury, patient felt unit continued pulling and pushed button to stop. No injury, therefore no medical treatment at time of incident or after. Product not returned to manufacturer for review. No indication event caused or contributed to permanent impairment, injury or death.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2014-00007
MDR Report Key3847675
Report Source04
Date Received2014-03-18
Date of Report2014-03-19
Date of Event2014-02-20
Date Added to Maude2014-06-19
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 STREET
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer Phone7607271280
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A., 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 NameTRITON
Generic NameTRITON TRACTION DOM PKG
Product CodeITH
Date Received2014-03-18
Model Number4739
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-03-18

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