MAUDE Adverse Event Report: UNKNOWN DRIVE; KNEE WALKER

Model Number 790

Device Problem Device Slipped (1584)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Drive devilbis healthcare is the initial importer of the device which is a knee walker.The unit has not been recovered for evaluation.End-user was recovering from left ankle achilles surgery.He is a "tall, big guy".On the second day the device slid out from under the user.He fell and landed on his right leg, he was diagnosed with a fractured/dislocated my ankle and broke tibia which required surgery.Patient was treated in a nursing home for 4 months.Handle height on product is 3.0875 feet.Product is discontinued.

• Brand Name: DRIVE
• Type of Device: KNEE WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9673461
• MDR Text Key: 178335632
• Report Number: 2438477-2020-00009
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2020
• Distributor Facility Aware Date: 02/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention