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

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Impaired Healing (2378)

Event Date 02/09/2015

Event Type  Injury  

Event Description

The event involves an elderly patient who experienced unexpected redness, swelling and delayed wound healing following total knee arthoplasty and the application of cold therapy.The patient had a history of valvular heart disease, hypertension and hypothyroidism and myelodysplastic syndrome.

• Brand Name: POLAR CARE GLACIER
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave. e; carlsbad CA 92010
• MDR Report Key: 4934686
• MDR Text Key: 6039155
• Report Number: 4934686
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR