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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 11193
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Breg customer service representative received an email from a distributor reporting post-op shoe failures.The bottom of the shoe separated from the top part.No injury was reported.
 
Manufacturer Narrative
The evaluation has 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.
 
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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 Key3602705
MDR Text Key21261112
Report Number2028253-2014-00002
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 01/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number11193
Device Catalogue Number11193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/02/2014
Initial Date FDA Received01/31/2014
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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