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

Model Number 10289BL

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's wife, who stated that "her husband was walking in the house and had a serious fall." there was no information provided regarding any defect, and the end user's wife stated that she was "unsure of what caused the fall." the end user cut his arm and injured his shoulder.Paramedics responded and transported the end user to the hospital, where he was admitted.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 17321459
• MDR Text Key: 319186537
• Report Number: 2438477-2023-00092
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 822383259338
• 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: 07/13/2023

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: 10289BL
• Device Catalogue Number: 10289BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2023
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 07/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male