MAUDE Adverse Event Report: BREG, INC POLAR CARE CUBE

Model Number 10701

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Nerve Damage (1979); Pain (1994); Disability (2371); No Code Available (3191)

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 of this alleged incident.

Event Description

Through legal notice breg, inc.Received a report of an alleged incident involving a polar care cube.The court document alleges that in 2018, the plaintiff suffered "focal necrosis, muscle wasting, and complex regional pain syndrome, which is a form of hyper-sensitive nerve damage that is irreversible, disabling, and extremely painful".

• Brand Name: POLAR CARE CUBE
• Type of Device: POLAR CARE CUBE
• Manufacturer (Section D): BREG, INC; 2885 loker avenue east; carlsbad, ca
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad, ca
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, ca ; 7955823
• MDR Report Key: 9727684
• MDR Text Key: 191860585
• Report Number: 2028253-2020-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736017647
• UDI-Public: 00672736017647
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10701
• Device Catalogue Number: 10701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Disability