MAUDE Adverse Event Report: ROSCOE MEDICAL; DELUXE POWDER COATED BED RAIL

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/05/2014

Event Type  Injury  

Event Description

The end-user was at her home and attempted to ambulate from her bed to the commode when a bed rail attached to her bed came apart or otherwise malfunctioned, causing her to fall.The end-user sustained an oblique fracture through the distal diaphysis of the right fibula, an equinus deformity of the foot, and complications resulting from internal implantation of an orthopedic device.

• Brand Name: ROSCOE MEDICAL
• Type of Device: DELUXE POWDER COATED BED RAIL
• MDR Report Key: 7283562
• MDR Text Key: 100508564
• Report Number: 3012316249-2018-00006
• Device Sequence Number: 1
• Product Code: FPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2018
• Distributor Facility Aware Date: 06/04/2016
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability