MAUDE Adverse Event Report: DJ ORTHO ICE MAN CLEAR CUBE

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 05/21/2014

Event Type  Injury  

Event Description

Patient reported that she received an electrical shock and burn to her shoulder while utilizing ice therapy machine and her cell phone.She was taken from her residence to the emergency department for evaluation.Diagnosis or reason for use: post operative cold therapy after shoulder surgery.Event abated after use stopped or dose reduced: yes.

• Brand Name: ICE MAN CLEAR CUBE
• Type of Device: ICE MAN CLEAR CUBE
• Manufacturer (Section D): DJ ORTHO
• MDR Report Key: 3866646
• MDR Text Key: 16802900
• Report Number: MW5036481
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR