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

Model Number	10701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation and it is not expected that product will be available for evaluation.Based on this, it will not be possible to establish if there was a malfunction involved in this alleged incident.A review of historical complaints in the last year has revealed that there have been no other reports of adverse events related to this issue.No malfunction involved with incident.Ifu states: "you may disconnect the cold therapy pad from the unit without removing the pad from the affected area by depressing the silver tabs on the hose coupling and gently pulling the hoses apart.The breg polar care cold therapy pad and unit will seal itself and will not leak.Note: some dripping during release is normal.".
Event or Problem Description
Breg received medwatch report alleging the following, "polar cube was disconnected in the patient's room and the cooling pad was worn by the patient underneath the bulky dressing (status post total knee arthroplasty).The ends of the tubes are supposed to seal when disconnected.While patient was participating in physical therapy, a small amount of water had dripped unnoticed on the steps.Patient slipped on the water while descending the stairs causing the leg to flex fully and internally rotate.5-6 drips of water were noted on the top steps while patient was sitting and resting on the steps.Patient required surgery later to repair a torn quad tendon".

• Brand Name: POLAR CARE CUBE
• Common Device Name: POLAR CARE CUBE
• Manufacturer (Section D): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• Manufacturer Contact: eduardo blanco ; 2885 loker ave east; carlsbad, CA 92010 ; 7607955906
• MDR Report Key: 16294436
• Report Number: 2028253-2023-00001
• Device Sequence Number: 12402723
• Product Code: ILO
• UDI-Device Identifier: 00672736017647
• UDI-Public: 00672736017647
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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: 10701
• Device Catalogue Number: 10701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 87 KG