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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DR. COMFORT, A DJO, LLC COMPANY DR COMFORT GSA WINNER BLACK 11.5 XWIDE; ORTHOSIS, CORRECTIVE SHOE
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DR. COMFORT, A DJO, LLC COMPANY DR COMFORT GSA WINNER BLACK 11.5 XWIDE; ORTHOSIS, CORRECTIVE SHOE Back to Search Results
Model Number 5710-X-11.5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
 
Event Description
It was reported that "the shoe was rubbing on top foot caused cut and infection".Further information was requested but not provided.
 
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Brand Name
DR COMFORT GSA WINNER BLACK 11.5 XWIDE
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 Key8699369
MDR Text Key148001594
Report Number3008579854-2019-00007
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 Other
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5710-X-11.5
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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