DR COMFORT 17-0004-0-00000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-09 for DR COMFORT 17-0004-0-00000 manufactured by Djo, Llc.

Event Text Entries

[101997012] Complaint received that alleges "patient developed ulcers, pt developing recurrent ulceration, patient developed huge ulcers from wearing the toe filler".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008579854-2018-00002
• MDR Report Key: 7327365
• Report Source: USER FACILITY
• Date Received: 2018-03-09
• Date of Report: 2018-03-09
• Date of Event: 2017-06-06
• Date Added to Maude: 2018-03-09
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: WILLIAM FISHER
• Manufacturer Street: 1430 DECISION STREET
• Manufacturer City: VISTA CA 920819663
• Manufacturer Country: US
• Manufacturer Postal: 920819663
• Manufacturer Phone: 7607343126
• Manufacturer G1: DR COMFORT, A DJO, LLC COMPANY
• Manufacturer Street: 10300 ENTERPRISE DRIVE
• Manufacturer City: MEQUON 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
• Generic Name: L5000 TOE FILLER CUSTOM INSOLE
• Product Code: KYS
• Date Received: 2018-03-09
• Returned To Mfg: 2018-03-05
• Model Number: 17-0004-0-00000
• 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. Other	2018-03-09