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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DR. COMFORT, A DJO, LLC COMPANY VICTORY WHITE VELCRO 10 WIDE; ORTHOSIS, CORRECTIVE SHOE

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DR. COMFORT, A DJO, LLC COMPANY VICTORY WHITE VELCRO 10 WIDE; ORTHOSIS, CORRECTIVE SHOE Back to Search Results
Model Number 3440-W-10.0
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Erosion (1750)
Event Date 12/19/2018
Event Type  malfunction  
Event Description
It was reported that the patient developed bleeding blisters during the break-in period of wearing the shoes.There was no report medical intervention required.
 
Manufacturer Narrative
The shoes were evaluated and no defect was found.
 
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Brand Name
VICTORY WHITE VELCRO 10 WIDE
Type of Device
ORTHOSIS, CORRECTIVE SHOE
Manufacturer (Section D)
DR. COMFORT, A DJO, LLC COMPANY
10300 enterprise dr.
mequon WI 53092
Manufacturer (Section G)
DR. COMFORT, A DJO, LLC COMPANY
10300 enterprise dr.
mequon WI 53092
Manufacturer Contact
brian becker
1430 decision street
vista, CA 92081-9663
7607343126
MDR Report Key8231780
MDR Text Key132567432
Report Number3008579854-2019-00002
Device Sequence Number1
Product Code KNP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/09/2019
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 Number3440-W-10.0
Device Lot NumberFY--39--18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Initial Date Manufacturer Received 12/19/2018
Initial Date FDA Received01/09/2019
Supplement Dates Manufacturer Received12/19/2018
Supplement Dates FDA Received01/09/2019
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 Unknown
Patient Sequence Number1
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