MAUDE Adverse Event Report: DJO, LLC DR COMFORT CLASSIC BLACK 10 XWIDE; ORTHOSIS, CORRECTIVE SHOE

Model Number 8410-X-10.0

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

Patient Problem Pressure Sores (2326)

Event Date 07/29/2019

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 "suffered.Foot ulcers on the heels of both feet.Not only did (patient) suffer from foot ulcers, he was left with the shoe impression embedded on both feet.This also caused, improper and negligent amputation of his big toe, and huge gashes to the heels of the bottom of both of his feet." no further information is currently available.

• Brand Name: DR COMFORT CLASSIC BLACK 10 XWIDE
• 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: 9777342
• MDR Text Key: 184332381
• Report Number: 3008579854-2020-00006
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8410-X-10.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• 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
• Patient Age: 59 YR