MAUDE Adverse Event Report: REMOVAL OF BEDRAILS; BED, MANUAL

Model Number NONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/14/2018

Event Type  Injury  

Event Description

Because of my fda rules to remove the rails from nursing home beds, my mother recently broke her leg in 2 places.She has had 6 surgeries on this leg and is now (b)(6).Now she has to suffer further with a broken leg.It wasn't bad enough that she is stuck in the nursing home but now i am greeted with why me questions, when it didn't need to be.What was the fda thinking, hospitals still have bed with rails.Her quality of life has gone downhill infinitely.Not every pt/resident should be as mom has stated: "i feel like i'm sleeping in a hole." the situation the fda created is ludicrous as if everyone fits your square box in health issues, we dont and you need to reverse this action and add flexibility.The minute of my brother and i (guardian) saw this configuration we knew this would happen.It's too bad the fda didn't see forward past what a mistake, it really was.

• Brand Name: REMOVAL OF BEDRAILS
• Type of Device: BED, MANUAL
• MDR Report Key: 7725809
• MDR Text Key: 115487888
• Report Number: MW5078660
• Device Sequence Number: 0
• Product Code: FNJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 92 YR
• Patient Weight: 71