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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 07/01/2015

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.Product involved in legal action.

Event Description

On may 12, 2017 breg's legal department received a report of an alleged incident involving a polar care kodiak unit.The incident alleges that on (b)(6) 2015 the following statement was noted by the patient's surgeon: "the wound is well demarcated.There is an avascular eschar overlying the anterior aspect of his left knee.Granulation tissue moving and from the periphery.We still do not have a good explanation for the cause of the skin necrosis.".

• Brand Name: POLAR CARE KODIAK
• Type of Device: POLAR CARE KODIAK
• 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: 6632489
• MDR Text Key: 77293751
• Report Number: 2028253-2017-00050
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• 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
• Patient Age: 19 YR