MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR

Model Number	RTL10266CF
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The device was not returned for evaluation.End-user was walking along the harbor when she noticed that the wheel was wobbling.They inspected the device and noticed that the wheel was bent inward.She continued to use the device and the front wheel buckled causing the rollator to collapse.End-user fell hitting her head on the cement.She was taken to the emergency room where tests were performed.No serious injury was sustained.Historical data for complaints of the same nature was reviewed and found to be very limited with no trend.There was a.0442 percent defect rate over the last two years.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lain du industry park; le liu town; shunde district, foshan city guangdong ; CH
• MDR Report Key: 10788889
• Report Number: 2438477-2018-00082
• Device Sequence Number: 3644556
• Product Code: ITJ
• UDI-Device Identifier: 00822383576817
• UDI-Public: 822383576817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 11/05/2020

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: RTL10266CF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2018
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• 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: Hospitalization
• Date Report Sent to FDA: 11/05/2020