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

Model Number 2760

Device Problem Insufficient Information (3190)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Complaint received from clinician that alleges "pt received 3rd degree burns".Questionnaire was received from clinician and/or pt.Pt received 2nd degree burn under one pad and a 3rd degree burn under one pad.Pt was seen by his doctor and a burn specialist for diagnosis and treatment, no description of treatment revealed to mfr.Device not returned to mfr for evaluation.

• Brand Name: CHATTANOOGA
• Type of Device: INTELECT LEGEND XT COMBOUS STD
• Manufacturer (Section D): DJO; 1430 decoision 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: 1430 decision st; vista, CA 92081 ; 7607271280
• MDR Report Key: 4420614
• MDR Text Key: 5417675
• Report Number: 9616086-2015-00001
• Device Sequence Number: 1
• Product Code: GZI
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2760
• 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: 27 YR
• Patient Weight: 75