MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; LEGEND XT

Model Number 2788

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/10/2015

Event Type  Injury  

Event Description

Per 21cfr part 803, an mdr reportable event.Complaint received from clinician that alleges "patient recd.Third degree burns while receiving treatment".Questionnaire was received from clinician and/or patient.Questionnaire states progress towards recovery was not impeded, treatment with silvadene ointment initiated.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.

• Brand Name: CHATTANOOGA
• Type of Device: LEGEND XT
• Manufacturer (Section D): DJO LLC; 1430 decision st.; 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: 140 decision st.; vista, CA 92081 ; 7607271280
• MDR Report Key: 4630156
• MDR Text Key: 16173328
• Report Number: 9616086-2015-00005
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2015

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: Health Professional
• Device Model Number: 2788
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2015
• 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: 76 YR
• Patient Weight: 122