MAUDE Adverse Event Report: DR. COMFORT, A DJO, LLC COMPANY WINNER X BLACK 12 XWIDE; ORTHOSIS, CORRECTIVE SHOE

Model Number 7710-X-12.0

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Ulcer (2274)

Event Date 12/09/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.If the device becomes available as such, a follow-up report will be submitted upon completion of the evaluation.

Event Description

It was reported that the patient had an open sore that got infected, requiring hospitalization, while wearing the shoes.The patient received the shoes on (b)(6) 2018 and wore them the same day.After wearing the shoes for four days, the patient got an open sore that wouldn't heal and became infected.The patient was hospitalized for three days.The shoes were reportedly "half an inch bigger on the toe".

Manufacturer Narrative

The shoes were returned for evaluation.No fault was found with these shoes.As such, the cause of the reported event was not determined.

• Brand Name: WINNER X BLACK 12 XWIDE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DR. COMFORT, A DJO, LLC COMPANY; 10300 enterprise dr.; mequon WI 53092
• Manufacturer (Section G): DR. COMFORT, A DJO, LLC COMPANY; 10300 enterprise dr.; mequon WI 53092
• Manufacturer Contact: brian becker ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8223323
• MDR Text Key: 132263298
• Report Number: 3008579854-2019-00001
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7710-X-12.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization