MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT TRANSPORT COMBO PKG US STD

Catalog Number	2738
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint received that alleges "screen will not light up, current is not steady burned a patient who later had skin grafts".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

• Brand Name: CHATTANOOGA
• Common Device Name: INTELECT TRANSPORT COMBO PKG US STD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6171096
• Report Number: 9616086-2016-00028
• Device Sequence Number: 828135
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 2738
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other