MAUDE Adverse Event Report: DRIVE; BED HANDLE

Model Number RTL15063-ADJ

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2020

Event Type  Death  

Event 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
• Type of Device: BED HANDLE
• MDR Report Key: 14395738
• MDR Text Key: 291617343
• Report Number: 2438477-2022-00045
• Device Sequence Number: 1
• Product Code: IKX
• UDI-Device Identifier: 00822383246192
• UDI-Public: 822383246192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2022,03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL15063-ADJ
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2022
• Distributor Facility Aware Date: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female