MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number 790

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 05/17/2017

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a knee walker.The incident was brought to the attention of pms through legal notification.The device was rented.It was returned to the rental service provider before an injury was identified.Maintenance records of this rental device need to be reviewed.Drive has no access to the device to perform investigation for root cause.Drive is filing this initial report with the intention of follow-up submissions when additional data becomes available.End-user had foot surgery which initiated rental and use of the device.He was at the zoo using the device when the latch holding the steering column failed and the column collapsed.The end-user fell onto his hand.The device was returned to the service provider.Three (3) days later the patient's hand turned black.The diagnosis was torn ligaments.Multiple surgeries were performed to address the issue.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7791485
• MDR Text Key: 117427196
• Report Number: 2438477-2018-00041
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 08/06/2018
• Distributor Facility Aware Date: 07/19/2018
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability