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

Model Number RTL10266CF

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving rollator by an end user, who stated that the "brake assembly broke and when he went to get up it wasn't locked, and it moved, and he ended up falling and fracturing his ribs." drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 16772844
• MDR Text Key: 313612585
• Report Number: 2438477-2022-00142
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• 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: 04/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266CF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Distributor Facility Aware Date: 10/14/2022
• Date Report to Manufacturer: 04/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG