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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE BED RAIL

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COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE BED RAIL Back to Search Results
Model Number 16500BV
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 03/14/2019
Event Type  Injury  
Event Description
(b)(6) is the initial importer of the device which is a bed rail. We are awaiting return of the device for evaluation. It is not believed that the device failed. The end user was trying to lower the rails from inside the bed and the rails got stuck. While reaching over she got her leg caught in the rail. She cut, right calf. Which required 29 stitches.
 
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Brand NameDRIVE
Type of DeviceBED RAIL
Manufacturer (Section D)
COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.
6 tongxing east rd
dongsheng town
zhongshan city, guangdong 52841 4
CH 528414
MDR Report Key8516221
MDR Text Key142034565
Report Number2438477-2019-00019
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 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16500BV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/15/2019
Distributor Facility Aware Date04/05/2019
Device Age7 MO
Event Location Nursing Home
Date Report to Manufacturer04/15/2019
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: 04/15/2019 Patient Sequence Number: 1
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