MAUDE Adverse Event Report: DR. COMFORT, A DJO, LLC COMPANY DR. COMFORT RELAX CHOCOLATE 10 WIDE; ORTHOSIS, CORRECTIVE SHOE

Model Number 5220-W-10.0

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

Patient Problem Unspecified Infection (1930)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

One pair of shoes was returned for evaluation.Upon inspection, no defect could be confirmed.

Event Description

It was reported that, after 30 days of using the shoes, the patient experienced ingrown toenails and infection on both big toes.The patient went to a foot doctor who prescribed an antibiotic to treat the infection.The infection was cleared after administration of the antibiotic.

• Brand Name: DR. COMFORT RELAX CHOCOLATE 10 WIDE
• 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 ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8682849
• MDR Text Key: 147462396
• Report Number: 3008579854-2019-00006
• 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: consumer
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5220-W-10.0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2019
• 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): Required Intervention