MAUDE Adverse Event Report: DRIVE; WHEELCHAIR

Model Number ATC19BL

Device Problem Material Integrity Problem (2978)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/05/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney, who reported that "the end user was seated in a transport chair when it collapsed due to a weld break causing him to fall and fracture his left scapula." 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: WHEELCHAIR
• MDR Report Key: 15455272
• MDR Text Key: 300235230
• Report Number: 2438477-2022-00072
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383133621
• UDI-Public: 00822383133621
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ATC19BL
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2022
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male