MAUDE Adverse Event Report: UNKNOWN DRIVE; KNEE WALKER

Model Number	790
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a knee walker.We have not been able to retrieve the device for evaluation.We do not have complete details of the environment in which the device was used.The ifu warns against use in uneven terrain.We are filing this report to be timely.It will be updated when additional information is available.End-user reported that as she was using the knee walker on the sidewalk outside her home when the unit broke.She fell hitting her knee on the cement sidewalk and bruised her knee badly.She went to the er where treatment received.She is under the care of an orthopedic surgeon as a result of the incident.

• Brand Name: DRIVE
• Common Device Name: KNEE WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11952098
• Report Number: 2438477-2021-00023
• Device Sequence Number: 4167307
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2021
• Report Date (Section F): 06/11/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 790
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 104
• Date Report Sent to FDA: 06/11/2021