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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG, INC. POLAR CARE 300
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BREG, INC. POLAR CARE 300 Back to Search Results
Model Number POLAR CARE 300
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Injury (2348)
Event Date 10/08/2010
Event Type  Injury  
Event Description
Breg received notification through fda's medwatch program of an alleged patient injury resulting from the use of a polar care 300 that 'malfunctioned' when used after arthroscopic surgery.No additional information was provided on the alleged 'malfunction'.
 
Manufacturer Narrative
No product was returned for evaluation.Breg has reviewed internal complaint files and finds no record of this incident previously being reported.This is the first notification received for this incident.This product was discontinued in (b)(6) of 2013.Device has not be returned.
 
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Brand Name
POLAR CARE 300
Type of Device
POLAR CARE 300
Manufacturer (Section D)
BREG, INC.
2885 loker avenue east
carlsbad CA 92010
Manufacturer (Section G)
BREG, INC.
2885 loker avenue east
carlsbad CA 92010
Manufacturer Contact
carol emerson
2885 loker avenue east
carlsbad, CA 92010
7607955823
MDR Report Key3676854
MDR Text Key15205512
Report Number2028253-2014-00008
Device Sequence Number1
Product Code ILO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Type of Report Initial
Report Date 03/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberPOLAR CARE 300
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/03/2014
Initial Date FDA Received03/13/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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