DR. COMFORT JUSTIN CHESTNUT 11 WIDE 5520-W-11.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-02 for DR. COMFORT JUSTIN CHESTNUT 11 WIDE 5520-W-11.0 manufactured by Djo, Llc.

MAUDE Entry Details

• Report Number: 3008579854-2019-00009
• MDR Report Key: 8755053
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-07-02
• Date of Report: 2019-07-02
• Date of Event: 2019-06-05
• Date Mfgr Received: 2019-06-05
• Device Manufacturer Date: 2019-03-31
• Date Added to Maude: 2019-07-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. BRIAN BECKER
• Manufacturer Street: 2900 LAKE VISTA DRIVE
• Manufacturer City: LEWISVILLE TX 75067
• Manufacturer Country: US
• Manufacturer Postal: 75067
• Manufacturer G1: DR. COMFORT, A DJO, LLC COMPANY
• Manufacturer Street: 10300 ENTERPRISE DR.
• Manufacturer City: MEQUON, WI 53092
• Manufacturer Country: US
• Manufacturer Postal Code: 53092
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DR. COMFORT JUSTIN CHESTNUT 11 WIDE
• Generic Name: ORTHOSIS, CORRECTIVE SHOE
• Product Code: KNP
• Date Received: 2019-07-02
• Returned To Mfg: 2019-06-05
• Model Number: 5520-W-11.0
• Lot Number: JP-03-19
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DJO, LLC
• Manufacturer Address: 1430 DECISION STREET VISTA CA 920819663 US 920819663

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-02