MAUDE Adverse Event Report: DR. COMFORT, A DJO, LLC COMPANY VICTORY WHITE VELCRO 10 WIDE; ORTHOSIS, CORRECTIVE SHOE

Model Number 3440-W-10.0

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Erosion (1750)

Event Date 12/19/2018

Event Type  malfunction  

Event Description

It was reported that the patient developed bleeding blisters during the break-in period of wearing the shoes.There was no report medical intervention required.

Manufacturer Narrative

The shoes were evaluated and no defect was found.

• Brand Name: VICTORY WHITE VELCRO 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 ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8231780
• MDR Text Key: 132567432
• Report Number: 3008579854-2019-00002
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3440-W-10.0
• Device Lot Number: FY--39--18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/09/2019
• 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: Unknown
• Patient Sequence Number: 1