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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DR COMFORT A5514 SPECIAL ACCOMM CUSTOM INSOLES; ORTHOSIS, CORRECTIVE SHOE
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DJO, LLC DR COMFORT A5514 SPECIAL ACCOMM CUSTOM INSOLES; ORTHOSIS, CORRECTIVE SHOE Back to Search Results
Model Number 17-0002-0-00000
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Injury (2348)
Event Date 01/15/2020
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 insert "caused pain or other trauma.Inserts were made from scan but patient's foot seems longer than insert.A wound has now formed on patient's foot.They are doing wound care and wound is healing." no further information is currently available.
 
Manufacturer Narrative
H3, h6: the a5514 special accomm custom insoles, serial number (b)(6), were returned for evaluation.They were compared to the respective foam mills of the customer's feet and found to be matching identically.Visual observation of the inserts revealed that the customer's toes were on edge, which caused displacement of the foot onto the inserts, resulting in a fit issue.
 
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Brand Name
DR COMFORT A5514 SPECIAL ACCOMM CUSTOM INSOLES
Type of Device
ORTHOSIS, CORRECTIVE SHOE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081
MDR Report Key9659571
MDR Text Key177399471
Report Number3008579854-2020-00002
Device Sequence Number1
Product Code KNP
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number17-0002-0-00000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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