MAUDE Adverse Event Report: DR COMFORT, A DJO, LLC COMPANY DR COMFORT; L5000 TMA TOE FILLER CUSTOM INSOLE

Model Number 12-3123-0-50000

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

Patient Problem Ulcer (2274)

Event Date 06/25/2018

Event Type  Injury  

Event Description

Complaint received that alleges "glue has come off the top cover that caused serious injury.Created ulcer on the sole of pts foot like a silver dollar size that may cause amputation to the pt".

• Brand Name: DR COMFORT
• Type of Device: L5000 TMA TOE FILLER CUSTOM INSOLE
• Manufacturer (Section D): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon CA 53092
• Manufacturer (Section G): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon CA 53092
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663
• MDR Report Key: 7654934
• MDR Text Key: 112880620
• Report Number: 3008579854-2018-00006
• Device Sequence Number: 1
• Product Code: KYS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 12-3123-0-50000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other