MAUDE Adverse Event Report: UNKNOWN DRIVE; KNEE WALKER

Model Number	790
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a knee walker.It was obtained from a service provider.We were notified of the incident upon receipt of legal documentation.We have no access to the device for evaluation.We will update this submission when more data becomes available.We are filing in an overabundance of caution.The end-user received the knee walker and it reportedly broke the same day.We do not know the specifics of the incident or the injury.

• Brand Name: DRIVE
• Common Device Name: KNEE WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8827235
• Report Number: 2438477-2019-00041
• Device Sequence Number: 19592913
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2019
• Report Date (Section F): 07/24/2019

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2019
• 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
• Date Report Sent to FDA: 07/24/2019