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

Model Number	1032
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.The reporter indicated that the device was discarded.
Event or Problem Description
It was reported that the moist heat pack burned through the pad during treatment.There was no reported patient harm.No further information was provided.

• Brand Name: CHATTANOOGA THERATHERM MOIST HEAT 14X27STD
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8786010
• Report Number: 2020737-2019-00007
• Device Sequence Number: 16571107
• Product Code: IRT
• UDI-Device Identifier: 00888912000147
• UDI-Public: 00888912000147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K770686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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 Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1