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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG, INC. ROADRUNNER
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BREG, INC. ROADRUNNER Back to Search Results
Model Number 06804
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for investigation.The reported incident states a roadrunner knee brace was used however the part number provided, pn 06804 is for a shortrunner knee brace.Breg has reviewed internal complaint files for both products and found no record of this incident previously being reported.This is the first notification received for this type of incident on either product.
 
Event Description
Breg received notification through fda's medwatch program of a patient who reported an abrasion on the upper section on the rear side of the knee joint while wearing the roadrunner knee brace.
 
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Brand Name
ROADRUNNER
Type of Device
ROADRUNNER
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 Key5726058
MDR Text Key48510022
Report Number2028253-2016-00005
Device Sequence Number1
Product Code IQI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number06804
Device Catalogue Number06804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
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