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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG INC. POLAR CARE 300; PACK, HOT/COLD WATER CIRCULATING
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BREG INC. POLAR CARE 300; PACK, HOT/COLD WATER CIRCULATING Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage/Bleeding (1888); Skin Discoloration (2074); Swelling (2091); Tissue Damage (2104); Partial thickness (Second Degree) Burn (2694)
Event Date 10/08/2010
Event Type  Other  
Event Description
In 2010 patient had arthroscopic knee surgery, first on her left knee and then on her right knee.Pt used the polar care 300 on the left knee without any issues but when patient used it on the right knee the machine "malfunctioned." pt went to dr (b)(6) and was diagnosed with tissue damage, swelling (3x it's normal size), and "freezer burn" (second degree burn) like damage to the skin.Pt also went to a dermatologist to address the skin discoloration and tissue damage which she still has to this day.She is still in physical therapy, acupuncture almost four years later due to the malfunction of the polar care 300 and will need medical care for the rest of her life.Pt states "this product is not safe to be on the market.It has no safety valve, and medicare should not pay for the use of this machine." pt also states that the damage to her knee has caused "hemorrhaging in her knee which causes blood to collect in her right foot.(turn black)." pt has already informed manufacturer.Pt is willing to provide any add'l info as well as pictures.Polar care 300 was delivered to the patient.By a third party company- (b)(6).
 
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Brand Name
POLAR CARE 300
Type of Device
PACK, HOT/COLD WATER CIRCULATING
Manufacturer (Section D)
BREG INC.
MDR Report Key3573285
MDR Text Key4142382
Report NumberMW5033821
Device Sequence Number1
Product Code ILO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Is the Reporter a Health Professional? No
Patient Sequence Number1
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