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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DR. COMFORT JUSTIN CHESTNUT 11 WIDE; ORTHOSIS, CORRECTIVE SHOE
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DJO, LLC DR. COMFORT JUSTIN CHESTNUT 11 WIDE; ORTHOSIS, CORRECTIVE SHOE Back to Search Results
Model Number 5520-W-11.0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
One pair of dr.Comfort justin chestnut 11 wide, part number: 5520-w-11.0, lot number: jp-03-19 was returned for evaluation.No fault was found with these shoes.The cause of the reported patient sores and infection could not be determined.
 
Event Description
It was reported that the patient developed sores and an infection.No further information was provided.
 
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Brand Name
DR. COMFORT JUSTIN CHESTNUT 11 WIDE
Type of Device
ORTHOSIS, CORRECTIVE SHOE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
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 Key8755053
MDR Text Key149846423
Report Number3008579854-2019-00009
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5520-W-11.0
Device Lot NumberJP-03-19
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2019
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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