MAUDE Adverse Event Report: DJO, LLC TRITON; TRITON TRACTION DOM PKG

Model Number 4739

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

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.

• Brand Name: TRITON
• Type of Device: TRITON TRACTION DOM PKG
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A., C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana 2224 4; MX 22244
• Manufacturer Contact: 1430 decision street; vista, CA 92081 ; 7607271280
• MDR Report Key: 3847675
• MDR Text Key: 4685568
• Report Number: 9616086-2014-00007
• Device Sequence Number: 1
• Product Code: ITH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4739
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 68