MAUDE Adverse Event Report: OSSUR AMERICAS, INC. REBOUND AIR WALKER MD; JOINT, ANKLE, EXTERNAL BRACE

Model Number B-242900003

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

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

Patient claim of pressure and swelling on tendons while wearing orthopedic walking boot.

• Brand Name: REBOUND AIR WALKER MD
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR AMERICAS, INC.; 27051 towne centre; foothill ranch CA 92610
• Manufacturer (Section G): OSSUR AMERICAS, INC.; 27051 towne centre; foothill ranch CA 92610
• Manufacturer Contact: crystal swafford ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823817
• MDR Report Key: 7455123
• MDR Text Key: 106330897
• Report Number: 2085446-2018-00001
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-242900003
• Device Catalogue Number: B-242900003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other