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

Model Number 10701

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 04/17/2014

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.A review of internal files from date of incident to date, identified no other reports for this alleged incident.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 third degree burns necessitating further surgery.

• 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: 5626055
• MDR Text Key: 44283312
• Report Number: 2028253-2016-00004
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• 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: 04/13/2016
• 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): Required Intervention