MAUDE Adverse Event Report: BREG, INC. PC CUBE

Model Number	10702
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Patient is still using the product.No indication of product malfunction.The polar care cube wrap was utilized without a protective barrier.The polar care instructions for use state: "proper pad application: instruct the patient that an insulation barrier must be between the polar care cold therapy pad and skin during use.No part of the polar care pad should touch the skin for any period of time.If a sterile dressing has been applied to the treatment site that does not completely cover the skin under the pad, instruct the patient to use an additional insulation barrier.The pad alone can be too cold to be applied directly to the skin.".An in-service was scheduled and held with the account on (b)(6) 2018.
Event or Problem Description
Reported incident of a burn on forearm of patient resulting from direct contact from polar care wrap.The following was communicated by email: ".The staff knows that there needs to be a barrier between the wrap and the skin, but apparently someone either did not make sure that there was a barrier, or did not educate the patient about this." unknown whether patient required medical or surgical intervention.No impairment or permanent damage sustained.

• Brand Name: PC CUBE
• Common Device Name: PC CUBE
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• MDR Report Key: 7321360
• Report Number: 2028253-2018-00003
• Device Sequence Number: 109746
• Product Code: ILO
• UDI-Device Identifier: 00672736017647
• UDI-Public: 00672736017647
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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: 10702
• Device Catalogue Number: 10702
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/07/2018
• 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