MAUDE Adverse Event Report: DRIVE; BED HANDLE

Model Number	RTL15063-ADJ
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2020
Type of Reportable Event	Death
Event or Problem Description
On march 24, 2022, drive devilbiss healthcare was first notified via service of a legal complaint of an incident that occurred on (b)(6) 2020 involving the bed assist handle, which is subject to a voluntary recall in cooperation with the cpsc implemented in december 2021.The complaint alleges wrongful death as a result of the end user's use of the bed assist handle.Drive is currently investigating the incident and will file an update if and when additional information becomes available.Drive encourages consumers who have the recalled bed handles to contact drive to participate in the voluntary recall and receive a refund.Please visit www.Recallrtr.Com/bedhandles, or drive's website at www.Drivemedical.Com (click on "important safety information" at the top of the page), or call (877) 467-3099 from 8:00 a.M.To 7:00 p.M.Et, monday through friday.

• Brand Name: DRIVE
• Common Device Name: BED HANDLE
• MDR Report Key: 14395738
• Report Number: 2438477-2022-00045
• Device Sequence Number: 2008579
• Product Code: IKX
• UDI-Device Identifier: 00822383246192
• UDI-Public: 822383246192
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/24/2022
• Report Date (Section F): 05/13/2022

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: RTL15063-ADJ
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2022
• 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: Death
• Patient Sex: Female
• Date Report Sent to FDA: 05/13/2022