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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 11192
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Breg customer service representative received a report from a distributor that the sole of a post-op shoe had separated from the shoe after 2 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 Key3631774
MDR Text Key4207474
Report Number2028253-2014-00005
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 02/17/2014
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 Number11192
Device Catalogue Number11192
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/21/2014
Initial Date FDA Received02/18/2014
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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