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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 Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Patient Problem Laceration(s) (1946)
Event Date 03/14/2019
Event Type  Injury  
Event Description
Drive devilbiss healthcare 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.
no.6, tongxing east road
dongsheng town
zhongshan city, guangdong 52841 4
CH 528414
MDR Report Key11580559
MDR Text Key242673788
Report Number3007222468-2019-00001
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Administrator/Supervisor
Remedial Action Relabeling
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 Received03/29/2021
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 Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/29/2021 Patient Sequence Number: 1
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