MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT LEGEND XT COMBOUS STD

Model Number 2760

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Scarring (2061)

Event Date 02/21/2012

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Per 21cfr part 803, an mdr reportable event.Complaint received via court summons that alleges "she alleges that during the course of receiving treatment with the machine, she sustained serious burns and scarring to her back".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: CHATTANOOGA
• Type of Device: INTELECT LEGEND XT COMBOUS STD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5022941
• MDR Text Key: 23801678
• Report Number: 9616086-2015-00023
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Disability