MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number K320ADDA-ELR

Device Problem Crack (1135)

Patient Problem Laceration(s) (1946)

Event Date 01/21/2017

Event Type  Injury  

Event Description

Drive is the initial importer of this device.The end-user locked the wheels of the device and attempted to stand by putting his weight on the armrests.The plastic on the right armrest and side rail cracked.The end-user allegedly received multiple cuts.A second incident two days later occurred when the front casters did not go over holes in the pavement causing the end-user to fall forward and hit his head.The patient sought medical attention due to bleeding, but no stitches were administered.Cuts were bandaged on both occasions.This report is based on information provided by end-user.

• Brand Name: DRIVE
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; 2 th nanwei road; zhenjiang; jiangsu,, 21200 00; CH 2120000
• MDR Report Key: 6345007
• MDR Text Key: 67807932
• Report Number: 2438477-2017-00017
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/21/2017,01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: K320ADDA-ELR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2017
• Device Age: 40 MO
• Event Location: Home
• Date Report to Manufacturer: 02/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 118