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

Model Number 10210-4ASM

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2019

Event Type  malfunction  

Event Description

Patients experiencing difficulties opening and closing legs of walkers.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE; 100 n barranca ave, suite 460; covina CA 91723
• MDR Report Key: 9481058
• MDR Text Key: 171618061
• Report Number: 9481058
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 50822383226205
• UDI-Public: (01)50822383226205
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/25/2019

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
• Device Operator: Health Professional
• Device Model Number: 10210-4ASM
• Device Lot Number: 5B211511
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1