MAUDE Adverse Event Report: UNKNOWN DRIVE; BED RAIL

Model Number 15201BV

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Pain (1994)

Event Date 10/26/2020

Event Type  Injury  

Event 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
• Type of Device: BED RAIL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10958401
• MDR Text Key: 219891648
• Report Number: 2438477-2020-00061
• Device Sequence Number: 1
• Product Code: FNJ
• UDI-Device Identifier: 00822383143026
• UDI-Public: 822383143026
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15201BV
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2020
• Distributor Facility Aware Date: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1