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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE BED RAIL

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UNKNOWN DRIVE BED RAIL Back to Search Results
Model Number 15201BV
Device Problem Unintended Movement (3026)
Patient Problems Fall (1848); Pain (1994)
Event Date 10/26/2020
Event Type  Injury  
Event Description
(b)(6) is the initial importer of the device which is a bed. We have not received the device for evaluation. We will file an updated report when we evaluate the device. This report is in response to medwatch filing 101545-2020-16. End-user was trying to get into bed. She grabbed the right side rail on the bed. She reported that the rail became shaky. She lost her balance, fell and hit her head. She complained of pain in sacral and coccyx area. The rail may have detached from the bed; however, this has not been confirmed. It is unknown whether a product defect or user error/lack of maintenance led to the incident. X-rays confirmed a fractured pelvis.
 
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Brand NameDRIVE
Type of DeviceBED RAIL
Manufacturer (Section D)
UNKNOWN
MDR Report Key10958401
MDR Text Key219891648
Report Number2438477-2020-00061
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 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15201BV
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2020
Distributor Facility Aware Date12/02/2020
Event Location No Information
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

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