MAUDE Adverse Event Report: BREG, INC. PC CUBE

Model Number 10702

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Type  Injury  

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 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
• Type of Device: PC CUBE
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 7321360
• MDR Text Key: 101831962
• Report Number: 2028253-2018-00003
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736017647
• UDI-Public: 00672736017647
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10702
• Device Catalogue Number: 10702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention