MAUDE Adverse Event Report: DJO, LLC DR. COMFORT PERFORMANCE X BLACK 12 WIDE; ORTHOSIS, CORRECTIVE SHOE

Model Number 9910-W-12.0

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

Patient Problem Pressure Sores (2326)

Event Date 08/22/2019

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 patient had a foot ulcer on his left foot (toe part)" there is a "rough part on the toe part inside the shoes.The patient is now going to the foot doctor to medicate the injured foot." no further information is currently available.

• Brand Name: DR. COMFORT PERFORMANCE X BLACK 12 WIDE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DR. COMFORT, A DJO, LLC COMPANY; 10300 enterprise dr.; mequon WI 59092
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9081112
• MDR Text Key: 158956284
• Report Number: 3008579854-2019-00012
• 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: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9910-W-12.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• 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 Number: 1
• Patient Outcome(s): Required Intervention