MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD. DRIVE; WALKER, MECHANICAL

Model Number 10289RD

Device Problem Material Integrity Problem (2978)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by the end user's daughter, who reported that the "rivet holding the handle for the left brake fell out" and caused the end user to fall and break her hip.Drive devilbiss healthcare is in the process of facilitating the return of the product for evaluation and will update this report should any additional information become available.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.; 1318 west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 18890445
• MDR Text Key: 337509613
• Report Number: 2438477-2024-00013
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 00822383259338
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024

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: 10289RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2024
• Distributor Facility Aware Date: 02/13/2024
• Date Report to Manufacturer: 03/12/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Sex: Female