MAUDE Adverse Event Report: DJO, LLC DONJOY ICEMAN CLEARCUBE W/UNIV WRAP-ON PAD, NS, RH, INT'L; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	11-1640
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that sparks came out of the power cords, and the end user suffered some degree of burning.It is unknown if this was on account of the formentioned sparks or due to frostbite.Further information was requested.

• Brand Name: DONJOY ICEMAN CLEARCUBE W/UNIV WRAP-ON PAD, NS, RH, INT'L
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8860952
• Report Number: 9616086-2019-00055
• Device Sequence Number: 19518547
• Product Code: ILO
• UDI-Device Identifier: 00888912218146
• UDI-Public: 00888912218146
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K955057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11-1640
• Device Lot Number: 082718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/05/2019
• 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: Required Intervention