MAUDE Adverse Event Report: DJO LLC ICEMAN CLASSIC CUBE; DONJOY

Model Number	11-0494
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained a cold burn while using the iceman unit, severity of the burn injury is unknown.
Additional Manufacturer Narrative
It was reported that the patient sustained a cold burn injury from the pad while using the iceman unit.The device was not returned for evaluation; photos of the injury were also not provided, it is inknown if medical treatment was provided to the patient.The root cause could not be established at this time.If additional information on this reported event becomes available this investigation will be reevaluated and a supplemental report will be submitted.

• Brand Name: ICEMAN CLASSIC CUBE
• Common Device Name: DONJOY
• 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.; 20230 parque industrial el flo; 20230 parque industrial el flo; tijuana, b.c. 22245 ,; MX 22245,
• Manufacturer Contact: mitchell dhority ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 25727431
• Report Number: 9616086-2026-00025
• Device Sequence Number: 13130821
• Product Code: ILO
• UDI-Device Identifier: 00888912003100
• UDI-Public: 00888912003100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: E201844
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: Lay User/Patient
• Device Model Number: 11-0494
• Device Catalogue Number: 11-0494
• Device Lot Number: 020426-04M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown