MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA HYDROCOLLATOR, E-2; UNIT, HEATING, POWERED

Model Number	2802
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	No Patient Involvement (2645); Patient Problem/Medical Problem (2688)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If the device is obtained, a follow-up report will be submitted upon completion of the product evaluation.
Event or Problem Description
It was reported that "the power plug connector and power cord plug on the back of the unit melted".There was no reported patient involvement.
Additional Manufacturer Narrative
E2, e3: unknown.H3, h6: the device was returned.Completion of the product evaluation confirmed the complaint - the power cord and connector had burned (melted).

• Brand Name: CHATTANOOGA HYDROCOLLATOR, E-2
• Common Device Name: UNIT, HEATING, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8625118
• Report Number: 9616086-2019-00023
• Device Sequence Number: 2386845
• Product Code: IRQ
• UDI-Device Identifier: 00888912022101
• UDI-Public: 00888912022101
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/20/2019

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: Health Professional
• Device Model Number: 2802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1