DR COMFORT 17-0001-0-00000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-02-23 for DR COMFORT 17-0001-0-00000 manufactured by Djo, Llc.

Event Text Entries

[100796199] Complaint received that alleges "patient had to be admitted to a wound care due to ulcer. Ulcer developed on dorsal aspect of the toes. There was no pain". Questionnaire not received from customer or clinician. Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008579854-2018-00001
• MDR Report Key: 7292457
• Report Source: DISTRIBUTOR
• Date Received: 2018-02-23
• Date of Event: 2017-08-01
• Date Added to Maude: 2018-02-23
• 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: A5513 REGULAR ACCOMM CUSTOM INSOLES
• Product Code: KYS
• Date Received: 2018-02-23
• Model Number: 17-0001-0-00000
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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. Hospitalization; 2. Other	2018-02-23