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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD. DRIVE BED RAIL

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FORT METAL PLASTIC CO., LTD. DRIVE BED RAIL Back to Search Results
Model Number 16500BV
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Suffocation (2088)
Event Date 03/07/2017
Event Type  Death  
Event Description
(b)(4) is the initial importer of the device in question. We received an email notification of the death of a patient from a nursing home. There seems to be inconsistency in the report from the facility. One person said that patient slid down off the side of the bed and her head got stuck at the end of the rail, while another suggested that the patient became stuck in between the bars of the rail. At this time, we do not know the type of bed to which the rail was paired, and how it was installed prior to the incident. This report is based on the information that was provided by the customer and attorney.
 
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Brand NameDRIVE
Type of DeviceBED RAIL
Manufacturer (Section D)
FORT METAL PLASTIC CO., LTD.
yi he civil affairs industrial
guongdong
guangdong, 51602 3
CH 516023
MDR Report Key6998128
MDR Text Key90929129
Report Number2438477-2017-00033
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/04/2017,03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other Health Care Professional
Device Model Number16500BV
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/07/2017
Event Location Nursing Home
Date Report to Manufacturer04/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/02/2017 Patient Sequence Number: 1
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