MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	795BU
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.A follow up will be submitted when additional information is available.The device moved unexpectedly while the user was getting out of f bed to use the restroom.The report stated that the brake failed to lock the wheels.The user fell to the floor and was bruised.She was taken to the hospital the next morning when she could not move.She was kept there for three days.Nothing was found to be broken.Her family plans to get her physical and occupational therapy.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12497546
• Report Number: 2438477-2021-00047
• Device Sequence Number: 19756671
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 822383221649
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/10/2021
• Report Date (Section F): 09/20/2021

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: 795BU
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2021
• Device Age: 15 MO
• Event Location: Home
• Date Report to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 42
• Date Report Sent to FDA: 09/20/2021