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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG, INC. POLAR CARE 300 89ILO

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BREG, INC. POLAR CARE 300 89ILO Back to Search Results
Model Number PC300
Event Type  Other  
Event Description

Breg received legal notice of 2 filed lawsuits each with multiple complainants, 34 in total, 16 for polar care 300, alleging "personal injury" after use of cold therapy. The extent of the "personal injury" is unk and reporter has no knowledge if this term meets the requirements of serious injury as defined by current fda guidelines. The dates of use in the lawsuit range from 2003 - 2010. Breg has reviewed internal complaint files and maude database and finds no record of previous notice of these "personal injury" claims. First notification was service of lawsuit on (b)(4) 2010. Used from (b)(6) 2006.

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Brand NamePOLAR CARE 300
Type of Device89ILO
Manufacturer (Section D)
vista CA 92081
Manufacturer Contact
kathleen barber
2611 commerce way
vista , CA 92081
MDR Report Key1752819
Report Number2028253-2010-00015
Device Sequence Number1
Product CodeILO
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/30/2010
1 Device Was Involved in the Event
16 PatientS WERE Involved in the Event:1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 
Date FDA Received07/06/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL NumberPC300
Device Catalogue Number09930
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/03/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Date Received: 07/06/2010 Patient Sequence Number: 8