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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 11182, 11193
Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Breg customer service representative ((b)(4)) received a call from distributor, commonwealth orthopaedics & rehab, reporting sole separating on post op shoes (p/n 11182 and 11193) after one and two weeks of use.No injury was reported.
 
Manufacturer Narrative
The evaluation has confirmed this as an adhesive failure although the root cause for the failure has not been determined.Breg is currently working with the manufacturer of the post-op shoe to determine root cause for the separation of the sole and identify appropriate corrective action.This investigation is being documented in supplier (b)(4).
 
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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
carlsabad 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 Key3591969
MDR Text Key4036931
Report Number2028253-2014-00001
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 01/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number11182, 11193
Device Catalogue Number11182, 11193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received12/27/2013
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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