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

Model Number	795B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fracture, Arm (2351)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.Consumer reportedly slid off the seat and broke her arm because the "footrest flipped backwards".Our tech support has advised that the proper use of the device would require the user to rest their feet on the footrest while in motion.The footrests cannot flip backwards in this instance.If the user was standing on the footrest to exit the device the device would flip forward and jostle the user.This is not recommended.We await return of the device for evaluation.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, ; CH
• MDR Report Key: 8824425
• Report Number: 2438477-2019-00042
• Device Sequence Number: 16987603
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2019
• Report Date (Section F): 07/24/2019

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: 795B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2019
• Device Age: 6 MO
• Date Report to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• 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 Weight: 61
• Date Report Sent to FDA: 07/24/2019