MAUDE Adverse Event Report: BREG, INC. BREG POLAR CARE CUBE

Model Number 10701

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Full thickness (Third Degree) Burn (2696)

Event Date 09/08/2011

Event Type  Injury  

Manufacturer Narrative

Retrospective review identified this report was not communicated for entry into the complaint system at time of legal service.Breg has reviewed internal complaint files and found no prior complaint associated with this alleged incident.No product was returned for evaluation.A review of internal files from january 2013 to march 11, 2016 did not identify any other instances of omission of entry into the complaint system.Device not returned to manufacturer.

Event Description

Breg received notification through the legal department of an alleged incident involving a polar care cube.The report alleges that the patient experienced a thermal injury in the form a full thickness burn on the left shoulder after using the polar care cube for approximately 23 hours subsequent to a left should arthroplasty.

• Brand Name: BREG POLAR CARE CUBE
• Type of Device: POLAR CARE 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: 5529709
• MDR Text Key: 41317485
• Report Number: 2028253-2016-00002
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10701
• Device Catalogue Number: 10701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention