MAUDE Adverse Event Report: DJO, LLC DR COMFORT L5000 TOE FILLER CUSTOM INSOLE; ORTHOSIS, CORRECTIVE SHOE

Model Number 17-0004-0-00000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/09/2020

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 insole caused a wound on patient's foot after one day of wear.Patient was treated in wound care.No further information is currently available.

• Brand Name: DR COMFORT L5000 TOE FILLER CUSTOM INSOLE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• Manufacturer (Section G): DR. COMFORT, A DJO, LLC COMPANY; 10300 enterprise dr.; mequon, wi
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, tx
• MDR Report Key: 9744950
• MDR Text Key: 180554735
• Report Number: 3008579854-2020-00005
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17-0004-0-00000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention