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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG, INC. BREG POLAR CARE KODIAK
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BREG, INC. BREG POLAR CARE KODIAK Back to Search Results
Model Number 10607
Device Problem Insufficient Information (3190)
Patient Problem Hematoma (1884)
Event Type  Injury  
Manufacturer Narrative
Product was received and tested, met all functional requirements.No evidence of damage or malfunction.Investigation is ongoing.
 
Event Description
Breg received a report of alleged frostbite after using a polar care kodiak cold therapy device.The patient received cold therapy treatment two days after undergoing acl surgery then again 2 weeks after surgery due to a hematoma on his leg.
 
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Brand Name
BREG POLAR CARE KODIAK
Type of Device
POLAR CARE KODIAK
Manufacturer (Section D)
BREG, INC.
2885 loker avenue east
carlsbad CA 92010
Manufacturer (Section G)
BREG, IINC.
2885 loker avenue east
carlsbad CA 92010
Manufacturer Contact
carol emerson
2885 loker avenue east
carlsbad, CA 92010
7607955823
MDR Report Key5066109
MDR Text Key25337168
Report Number2028253-2015-00007
Device Sequence Number1
Product Code ILO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Report Date 09/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Model Number10607
Device Catalogue Number10607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age15 YR
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