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

Model Number 2760

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "was burned by electrotherapy treatment".Questionnaire not received from clinician and/or patient, photo received showed large blisters and red area where pads had been applied.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.

• 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: 5473865
• MDR Text Key: 39457739
• Report Number: 9616086-2016-00007
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 03/02/2016

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: Health Professional
• Device Model Number: 2760
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other