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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG, INC BREG POST-OP SHOE
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BREG, INC BREG POST-OP SHOE Back to Search Results
Model Number 11194
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2013
Event Type  malfunction  
Event Description
Breg sales representative called breg customer service representative to communicate a report from a distributor indicating the sole of a post-op shoe separating from the sole after two months of use.No report of injury.
 
Manufacturer Narrative
The evaluation confirmed separation of the sole from the shoe.The root cause for the failure has not been determined and is being investigated.The supplier of the post-op shoe has been issued a corrective action.Breg is no longer distributing this post-op shoe.
 
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Brand Name
BREG POST-OP SHOE
Type of Device
POST-OP SHOE
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 Key3629476
MDR Text Key4180318
Report Number2028253-2014-00004
Device Sequence Number1
Product Code IQI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number11194
Device Catalogue Number11194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/17/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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