MAUDE Adverse Event Report: OSSUR AMERICAS ACTIVE OFFLOADING WALKER LARGE BLACK; JOINT, ANKLE, EXTERNAL BRACE

Model Number DH0800BLK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulcer (2274); Pressure Sores (2326)

Event Date 06/06/2016

Event Type  Injury  

Event Description

Patient developed ulcers on the shin and sole of foot within 3 weeks of wearing the active offloading walker boot.

Event Description

Patient developed ulcers on the shin and sole of foot within 3 weeks of wearing the active offloading walker boot.The patient had a preexisting wound on the lateral aspect of his foot and the practitioner was treating the wound with the ossur diabetic walker for 5 weeks.At the 5 week point, the patient started breaking down near the midpoint of his foot creating an ulcer, which was believed to be caused by the friction and rubbing of the walker.The patient does not have a normal gait because of a bone deformity causing him to walk on the outside of his foot.

• Brand Name: ACTIVE OFFLOADING WALKER LARGE BLACK
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer (Section G): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5770647
• MDR Text Key: 48818131
• Report Number: 2085446-2016-00004
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DH0800BLK
• Device Catalogue Number: DH0800BLK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other