MAUDE Adverse Event Report: OSSUR HF REBOUND AIR WALKER; EXTERNAL BRACE

Model Number B-242900004E

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

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Patient reported injury regarding severely reduced blood circulation leading to acute thrombosis.It is unclear which other (dvt risk) factors could have contributed to this injury.Circumstances are under investigation in order to determine the potential contributing role of the walker.Ossur is not aware of similar injuries due to the use of the rebound air walker.

Event Description

Acute thrombosis occluding the sfa, popliteal, peroneal and gastrocnemius veins.This resulted in admission to hospital for 3 days and blood thinner for 3 months.

Manufacturer Narrative

The patient had developed dvt after approximately a month of wearing the device the patient is recovering from the dvt and is on blood thinners and wearing compression socks to aid in his recovery.There is generally an inherent risk of dvt when being immobilized.Based on a population study there was, "an eight-fold increased risk of venous thrombosis found in patients with below-knee cast immobilization.The risk was particularly high (56-fold increased) in the first 3 months, during which 90% of cases occurred." the patient indicated that he had limited movement as he mainly sat at an office and went on short walks when needing to get around the building.Therefore it is considered most likely that limited movement contributed to the injury developed.Although root cause of the injury as described is not likely to be related to the device, this cannot be confirmed as product is not available for investigation.In a 5-year trend analysis of all ossur's walker boots, no other occurrences of dvt have been observed.This is the first event/injury case.

Event Description

Acute thrombosis occluding the sfa, popliteal, peroneal and gastrocnemius veins.This resulted in admission to hospital for 3 days and blood thinner for 3 months.

• Brand Name: REBOUND AIR WALKER
• Type of Device: EXTERNAL BRACE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8614756
• MDR Text Key: 145208659
• Report Number: 0002085446-2019-00001
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-242900004E
• Device Catalogue Number: B-242900004E
• Device Lot Number: WB180926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other