MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE DRIVE; WALKER, MECHANICAL

Model Number	10210-4ASM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upon demonstrating rolling walker to issue to patient for home, noted to be defective requiring excessive force to close right- hand side.Replaced with a new walker, which functioned appropriately.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE; 99 seaview blve suite 210; port washington NY 11050
• MDR Report Key: 9853172
• Report Number: 9853172
• Device Sequence Number: 19499068
• Product Code: ITJ
• UDI-Device Identifier: 00822383226200
• UDI-Public: (01)00822383226200
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/18/2020
• Report Date (Section F): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10210-4ASM
• Device Lot Number: 5B11505
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 125
• Date Report Sent to FDA: 02/18/2020