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

Model Number R726BL

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by the end-user's daughter, who stated that the back left leg of the rollator broke while in use, causing the end user to fall.The fall reportedly resulted in bruises on her tailbone, arm and back, and a fifth metatarsal fracture in her foot, requiring a stabilizing shoe for her foot.Drive devilbiss healthcare is currently investigating the incident, including requesting the return of the device for evaluation, and an update will be filed if additional information becomes available.

Manufacturer Narrative

Drive devilbiss healthcare previously reported the incorrect manufacturer name and address in section d3 and f14.The information has been updated in these sections to reflect the correct manufacturer name and address.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.; 1318 west of tanjialing road; west district; yuyao, zhejiang 52840 0; CH 528400
• MDR Report Key: 18238253
• MDR Text Key: 329380206
• Report Number: 2438477-2023-00145
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: 00822383233208
• 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,Followup
• Report Date: 12/01/2023

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: R726BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2023
• Distributor Facility Aware Date: 11/02/2023
• Event Location: Other
• Date Report to Manufacturer: 12/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Sex: Female