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

Model Number 11-1422

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/15/2021

Event Type  Injury  

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 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
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el flirdo; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 11780300
• MDR Text Key: 249202137
• Report Number: 9616086-2021-00007
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00888912005869
• UDI-Public: 00888912005869
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1422
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other