MAUDE Adverse Event Report: UNKNOWN DRIVE; BED RAIL

Model Number	15201BV
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a bed.We have not received the device for evaluation.We will file an updated report when we evaluate the device.This report is in response to medwatch filing 101545-2020-16.End-user was trying to get into bed.She grabbed the right side rail on the bed.She reported that the rail became shaky.She lost her balance, fell and hit her head.She complained of pain in sacral and coccyx area.The rail may have detached from the bed; however, this has not been confirmed.It is unknown whether a product defect or user error/lack of maintenance led to the incident.X-rays confirmed a fractured pelvis.

• Brand Name: DRIVE
• Common Device Name: BED RAIL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10958401
• Report Number: 2438477-2020-00061
• Device Sequence Number: 3189663
• Product Code: FNJ
• UDI-Device Identifier: 00822383143026
• UDI-Public: 822383143026
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/07/2020
• Report Date (Section F): 12/07/2020

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: 15201BV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/07/2020