MAUDE Adverse Event Report: BREG, INC. BREG; PACK, HOT OR COLD, WATER CIRCULATING

Model Number POLAR CARE CUBE

Device Problems Leak/Splash (1354); Failure to Seal (4070)

Patient Problems Fall (1848); Muscle/Tendon Damage (4532)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

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: BREG
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave e; carlsbad CA 92010
• MDR Report Key: 16130062
• MDR Text Key: 307011769
• Report Number: 16130062
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: POLAR CARE CUBE
• Device Catalogue Number: 10701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White