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

Model Number	10289BL
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2017-00083
• Device Sequence Number: 16466808
• Product Code: ITJ
• UDI-Device Identifier: 00822383259345
• UDI-Public: 822383259345
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 10/03/2017
• Report Date (Section F): 11/02/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10289BL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2017
• Device Age: 22 MO
• Event Location: Home
• Date Report to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2017
• 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: 62 YR
• Patient Weight: 71
• Date Report Sent to FDA: 11/02/2017