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

Model Number	16500BV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: DRIVE
• Common Device Name: BED 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 Key: 8516221
• Report Number: 2438477-2019-00019
• Device Sequence Number: 1955790
• Product Code: FNJ
• UDI-Device Identifier: 00822383160498
• UDI-Public: 822383160498
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2019
• Report Date (Section F): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 16500BV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2019
• Device Age: 7 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 55
• Date Report Sent to FDA: 04/15/2019