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

Model Number RTL10266

Device Problem Insufficient Information (3190)

Patient Problem Swelling/ Edema (4577)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user, who stated that "there is a part by the right wheel that caused me an injury." the end user did not specify whether there was any malfunction of the rollator, what part was involved, or whether or how the part was defective.The end user reportedly experienced swelling and was given antibiotics as a result of the otherwise unspecified injury.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, guandong ; CH
• MDR Report Key: 17147844
• MDR Text Key: 317533568
• Report Number: 2438477-2023-00076
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• 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: 06/16/2023,06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Distributor Facility Aware Date: 05/08/2023
• Device Age: 10 MO
• Date Report to Manufacturer: 06/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female