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

Model Number 10289BL

Device Problem Break (1069)

Patient Problem Damage to Ligament(s) (1952)

Event Date 06/05/2023

Event Type  Injury  

Event Description

(b)(6) was notified of an incident involving a rollator by an end user who stated that "the front wheel broke off and the unit broke while crossing the street." the end user was treated at an urgent care facility, where her wrist and knee were bandaged.Drive requested that the unit be returned for evaluation, 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: 17262488
• MDR Text Key: 318445419
• Report Number: 2438477-2023-00089
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 07/05/2023

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: 07/05/2023
• Distributor Facility Aware Date: 06/07/2023
• Device Age: 4 YR
• Date Report to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization