MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; THERATHERM MOIST HEAT 14X27STD

Model Number	1032
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received that alleges "heating pad started sparking and caught fire".Questionnaire not received from customer or clinician.Device not returned for evaluation.Oem notified of complaint.

• Brand Name: CHATTANOOGA
• Common Device Name: THERATHERM MOIST HEAT 14X27STD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6050684
• Report Number: 2020737-2016-00014
• Device Sequence Number: 19307174
• Product Code: IRT
• UDI-Device Identifier: 00888912000147
• UDI-Public: 00888912000147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2016
• Report Date (Section F): 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1032
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/17/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2016
• 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
• Date Report Sent to FDA: 10/24/2016