MAUDE Adverse Event Report: DJO, LLC DONJOY ICEMAN; ICEMAN CLEAR3

Model Number 11-1635

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

Patient Problems Burn(s) (1757); Fall (1848); Shock (2072); Loss of consciousness (2418)

Event Date 05/30/2014

Event Type  Injury  

Event Description

Complaint received from clinician that alleges "using cell phone when she received shock and a burn to the back of her right shoulder.Lost consciousness and woke up on the floor".Questionnaire not received from clinician and/or patient.Product returned to manufacturer for review.The device showed no signs of physical damage and the device's dielectric integrity was found to un-violated, by insulation breakdown, water penetration, exposed conductors or any physical damage that could result in a conductive path from the patient to ac mains or secondary voltage (dc output of power supply and drive voltage to pump).From the inspection and test results the iceman clear3 device in question does not exhibit a conductive path from the patient applied part to ac mains.The iceman clear3 presented did not demonstrate the capability to act as the source of or a current path for an electrical shock.

• Brand Name: DONJOY ICEMAN
• Type of Device: ICEMAN CLEAR3
• Manufacturer (Section D): DJO, LLC; 1430 decision st.; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana b.c. 2224 4; MX 22244
• Manufacturer Contact: 1430 decision st.; vista, CA 92081 ; 7607271280
• MDR Report Key: 3975131
• MDR Text Key: 4750130
• Report Number: 9616086-2014-00012
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1635
• Device Lot Number: 021212-03B
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other