MAUDE Adverse Event Report: DJO LLC ICEMAN, COLD THERAPY SYSTEM; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	11-1422
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the hospital staff that a cold therapy machine (iceman classic cube) allegedly caused tissue damage after the patient had the unit for 2 days.After further discussions with the nurse and she stated that the patient tested positive for meth and believes it was the root cause of the reported injury.The ifu states limit the use of this device with patients who are unresponsive, incapacitated, have altered mental status or altered pain perception.Post-surgical patients under sedation or on analgesics or anesthetics, as well as patients taking hypnotics, anxiolytics, or antidepressants, must be monitored frequently during use of this device.These patients may not be able to perceive pain, burning, numbness, tingling or decreased sensation and may be susceptible to injury.Discontinue cold therapy immediately at the first sign of cold injury.Use of this device without a prescription or failure to follow the prescription may result in serious injury, including tissue necrosis.
Event or Problem Description
It was reported by the hospital staff that a cold therapy machine (iceman classic cube) allegedly caused tissue damage after the patient had the unit for 2 days.

• Brand Name: ICEMAN, COLD THERAPY SYSTEM
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• MDR Report Key: 11780300
• Report Number: 9616086-2021-00007
• Device Sequence Number: 3854439
• Product Code: ILO
• UDI-Device Identifier: 00888912005869
• UDI-Public: 00888912005869
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 11-1422
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/05/2021
• 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