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

Model Number 10901

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

Patient Problems Burn(s) (1757); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation, nor lot number provided.A review of internal files from date of incident to date identified no other reports for this alleged incident.

Event Description

Through legal notice breg, inc.Received a report of an alleged incident involving a polar care glacier.The court document alleges that on or before (b)(6) 2017, a plaintiff, "sustained a non-freezing cold injury resulting in her permanent disfigurement and disability".

Manufacturer Narrative

On february 2, 2023, the device history record for lot number 262119126 was reviewed after breg was made aware of the lot number associated with mdr: 2028253-2019-00002.Polar glacier device from lot number 262119126 was manufactured on december 21, 2016.A device history for the lot involved #262119126 was reviewed.There were no non-conformances reports or deviations issued during the manufacturing of the product.No changes on materials or manufacturing processes were made.All in process inspections passed, no anomalies were identified during the manufacturing of the lot.Final inspection requirements were met prior to release.

Event Description

On february 2, 2023, the device history record for lot number 262119126 was reviewed after breg was made aware of the lot number associated with mdr: 2028253-2019-00002.

• Brand Name: POLAR CARE GLACIER
• Type of Device: POLAR CARE GLACIER
• 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 ave east; carlsbad, CA 92010 ; 7607955906
• MDR Report Key: 8741820
• MDR Text Key: 149485225
• Report Number: 2028253-2019-00002
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736021699
• UDI-Public: 00672736021699
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 10901
• Device Catalogue Number: 10901
• Device Lot Number: 262119126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: No
• 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 Sex: Female