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

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.

• Brand Name: DRIVE
• Type of Device: BED 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 Key: 11580559
• MDR Text Key: 242673788
• Report Number: 3007222468-2019-00001
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 16500BV
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 55