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

Model Number	10901
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2028253-2019-00002
• Device Sequence Number: 19217673
• Product Code: ILO
• UDI-Device Identifier: 00672736021699
• UDI-Public: 00672736021699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female