MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; TRITON DTS

Catalog Number 2841

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

Complaint received from user facility that alleges "unit does not stop pulling".Product not received for evaluation or review.No additional information received from clinician/facility.Complaint did not indicate event caused or contributed to permanent impairment, injury or death.No patient involvement indicated in complaint.

• Brand Name: CHATTANOOGA
• Type of Device: TRITON DTS
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana b.c. 2224 4; MX 22244
• Manufacturer Contact: 1430 decision street; vista, CA 92081
• MDR Report Key: 3865205
• MDR Text Key: 4457065
• Report Number: 9616086-2014-00004
• Device Sequence Number: 1
• Product Code: ITH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2841
• 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