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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG POLAR CARE KODIAK
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BREG POLAR CARE KODIAK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Disability (2371); Burn, Thermal (2530)
Event Date 01/29/2013
Event Type  Injury  
Event Description
Patient was given a breg polarcare ctu following surgery in early 2014.After using the product in keeping with the product's guidelines, patient sustained full-thickness skin injuries requiring multiple surgeries.While more surgery will be required, patient will remain permanently disabled.
 
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Brand Name
POLAR CARE KODIAK
Type of Device
POLAR CARE KODIAK
Manufacturer (Section D)
BREG
MDR Report Key3877369
MDR Text Key4462559
Report NumberMW5036630
Device Sequence Number1
Product Code ILO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
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