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

Model Number 10601

Device Problem No Apparent Adverse Event (3189)

Patient Problem Electric Shock (2554)

Event Date 09/03/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 301700173
• Report Number: 2028253-2022-00004
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736000625
• UDI-Public: 00672736000625
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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 Age: 54 YR
• Patient Sex: Male