MAUDE Adverse Event Report: EEWELL HOMECARE PRODUCTS CO., LTD DRIVE; ROLLATOR

Model Number 10289BL

Device Problems Bent (1059); Collapse (1099)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/27/2017

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device.End-user was using device in the home in an area where outdoor carpet and tiles converged.At the bump in the flooring the front wheel collapsed.She fell and fractured her foot.The item was returned and evaluated.Item returned on rma (b)(4) had a complaint of the front wheel collapsing.The unit shows moderate use with no significant damage to the frame or wheels.The brakes on both sides are conforming.The front wheel has bent forward and downward but shows no damage to the wheel or front fork.Root cause may be attributed to material damage due to welding.The normal structure may not have been strong enough due to damaged material.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): EEWELL HOMECARE PRODUCTS CO., LTD; xilian new street; yihe management area; yuanzhou town, guangdong 51621 9; CH 516219
• MDR Report Key: 6998165
• MDR Text Key: 90937616
• Report Number: 2438477-2017-00083
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383259345
• UDI-Public: 822383259345
• 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
• Type of Report: Initial
• Report Date: 11/02/2017,10/03/2017

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: 10289BL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2017
• Distributor Facility Aware Date: 10/03/2017
• Device Age: 22 MO
• Event Location: Home
• Date Report to Manufacturer: 11/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71