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

Model Number RTL10266CF

Device Problem Material Deformation (2976)

Patient Problem Fall (1848)

Event Date 08/19/2018

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 214743631
• Report Number: 2438477-2018-00082
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383576817
• UDI-Public: 822383576817
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2020,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266CF
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2020
• Distributor Facility Aware Date: 08/20/2018
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization