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

Model Number 10701

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Returned device was evaluated and found to meet all functional requirements.Reported incident was not confirmed.A review of historical complaint records indicate this is the first notification breg received related to this incident.

Event Description

Breg received medwatch report alleging leaking of pc cube unit.No report of injury involved with the report.

• Brand Name: 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: 6916444
• MDR Text Key: 89929246
• Report Number: 2028253-2017-00077
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10701
• Device Catalogue Number: 10701
• Device Lot Number: 272130207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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