DEROYAL ANKLE CONTRACTURE BOOT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-27 for DEROYAL ANKLE CONTRACTURE BOOT * manufactured by Deroyal.

Event Text Entries

[1949189] Patient developed a deep tissue injury to right achilles related to pressure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2073762
• MDR Report Key: 2073762
• Date Received: 2011-04-27
• Date of Report: 2011-04-27
• Date of Event: 2011-04-11
• Report Date: 2011-04-27
• Date Reported to FDA: 2011-04-27
• Date Added to Maude: 2011-05-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DEROYAL ANKLE CONTRACTURE BOOT
• Generic Name: ANKLE CONTRACTURE BOOT
• Product Code: ITW
• Date Received: 2011-04-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEROYAL
• Manufacturer Address: 200 DEBUSK LANE POWELL TN 37849 US 37849

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-04-27