MAUDE Adverse Event Report: DR COMFORT, A DJO, LLC COMPANY DR COMFORT; KATY GREEN/TURQUOISE 8 1/2 XWI

Model Number 37725-X-08.5

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

Patient Problem Infection, Direct (2244)

Event Date 05/31/2018

Event Type  Injury  

Event Description

Complaint received that alleges "the shoes katy green/turquoise 08.5 xw caused her an infection that will lead to amputation of her left foot".

• Brand Name: DR COMFORT
• Type of Device: KATY GREEN/TURQUOISE 8 1/2 XWI
• 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: 7591854
• MDR Text Key: 110761842
• Report Number: 3008579854-2018-00004
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37725-X-08.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Disability