MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; HYDROCOLLATOR, M-2, C/W 12 STD. PACKS

Model Number	2402
Medical Device Problem Codes	Smoking (1585); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit overheating on low thermostat setting, reported that on monday (b)(6) 2025 the football coach stated that he walked into the training room and saw black smoke coming from the hydrocollator.He opened it up and smoke came rolling out.It was unplugged and it was taken outside, fire department was contacted and they did not have a report, no injury or damages occurred at the time of the incident.
Additional Manufacturer Narrative
It was reported that the unit overheating on low thermostat setting, reported that on monday (b)(6) 2025 the football coach stated that he walked into the training room and saw black smoke coming from the hydrocollator.He opened it up and smoke came rolling out.It was unplugged and it was taken outside, fire department was contacted and they did not have a report, no injury or damages occurred at the time of the incident.The device has not been returned for evaluation, the root cause could not be established.Additional reporting on this event will be provided as a supplemental report to this document if new information becomes available.

• Brand Name: CHATTANOOGA
• Common Device Name: HYDROCOLLATOR, M-2, C/W 12 STD. PACKS
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera lobre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245, mex 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 23700710
• Report Number: 9616086-2025-00071
• Device Sequence Number: 16120422
• Product Code: IRQ
• UDI-Device Identifier: 00888912021449
• UDI-Public: 00888912021449
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: D081266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown