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

Model Number	10601
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation since it was discarded by customer.A review of internal files from date of incident to date identified no other reports for this alleged incident.No additional information has been provided.The device history record for lot number 20222692605 was reviewed.The product met all functional and release requirements prior to release for distribution.
Event or Problem Description
Breg received medwatch report alleging the following, "patient reported to his nurse that his polar ice machine had shocked his knee while lying in bed.This occurred 3 times".No report of injury involved with the report.

• Brand Name: POLAR CARE KODIAK
• Common Device Name: POLAR CARE KODIAK
• Manufacturer (Section D): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: eduardo blanco ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955906
• MDR Report Key: 15591827
• Report Number: 2028253-2022-00004
• Device Sequence Number: 2072061
• Product Code: ILO
• UDI-Device Identifier: 00672736000625
• UDI-Public: 00672736000625
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 20222692605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male