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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DR. COMFORT, A DJO, LLC COMPANY DR. COMFORT SHOE MODIFICATION; ORTHOSIS, CORRECTIVE SHOE
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DR. COMFORT, A DJO, LLC COMPANY DR. COMFORT SHOE MODIFICATION; ORTHOSIS, CORRECTIVE SHOE Back to Search Results
Model Number 17-0050-0-00000
Device Problem Unstable (1667)
Patient Problem Fall (1848)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
Tread ease was added to the shoe, which was requested on the original order.No defect was identified.
 
Event Description
It was reported that the shoe(s) "caused pain.Patient had requested extra treadease because he was slipping and falling in his shoes.The new extra are far slipperier and he fell twice and injured his ankle.[sic] further information was provided that the patient had "just a twisted ankle" and "did not need medical treatment, just iced it at home and wrapped it with an ace bandage.".
 
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Brand Name
DR. COMFORT SHOE MODIFICATION
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
2900 lake vista drive
lewisville, TX 75067
MDR Report Key8741144
MDR Text Key162365260
Report Number3008579854-2019-00008
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 distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number17-0050-0-00000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Date Manufacturer Received06/03/2019
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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