MAUDE Adverse Event Report: STANDER, INC. STANDER, INC. BED RAIL ASSISTANCE DEVICE; ADULT PORTABLE BED RAILS FOR MEDICAL PURPOSES

Model Number 21-142

Patient Problems Fall (1848); Physical Entrapment (2327)

Event Date 07/16/2023

Event Type  Death  

Event Description

A resident hung her neck on the bar as she fell out of bed.

• Brand Name: STANDER, INC. BED RAIL ASSISTANCE DEVICE
• Type of Device: ADULT PORTABLE BED RAILS FOR MEDICAL PURPOSES
• Manufacturer (Section D): STANDER, INC.; logan UT 84321
• MDR Report Key: 17388386
• MDR Text Key: 319751547
• Report Number: MW5119958
• Device Sequence Number: 1
• Product Code: QTC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 21-142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White