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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REMOVAL OF BEDRAILS BED, MANUAL

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REMOVAL OF BEDRAILS BED, MANUAL Back to Search Results
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.
 
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Brand NameREMOVAL OF BEDRAILS
Type of DeviceBED, MANUAL
MDR Report Key7725809
MDR Text Key115487888
Report NumberMW5078660
Device Sequence Number0
Product Code FNJ
Reporter Country CodeUS
Number of Events Reported1
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 Received07/26/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNONE
Device Catalogue NumberNONE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/26/2018 Patient Sequence Number: 1
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