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

Model Number	RTL10266CF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user who stated that a wheel broke and "sent [her] backwards onto the floor." the end user was reportedly taken to the hospital where she was diagnosed with shoulder fractures and dislocation.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• 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, guangdong ; CH
• MDR Report Key: 17615306
• Report Number: 2438477-2023-00113
• Device Sequence Number: 7457258
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 08/24/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266CF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2023
• Device Age: 6 YR
• Date Report to Manufacturer: 08/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Date Report Sent to FDA: 08/24/2023