MAUDE Adverse Event Report: FUYANG HONGWEI METAL PRODUCT CO., LTD. DRIVE; ROLLATOR

Model Number 10257RD-1

Device Problems Collapse (1099); Device Issue (2379)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a complaint from the granddaughter of a patient using a rollator that drive devilbiss healthcare imports and distributes.The patient was using the rollator when he hit a small bump allegedly causing the entire rollator to collapse.He fell to the ground, injuring his head.He was rushed to urgent care immediately after the incident.She is claiming that the lock keeping the rollator open is non-functional and unsafe.The alleged product has not been returned to drive devilbiss healthcare for evaluation.This report is based on the information provided by the patient's granddaughter.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): FUYANG HONGWEI METAL PRODUCT CO., LTD.; liaoan village; wanshi town; fuyang city, zhejiang 31140 6; CH 311406
• MDR Report Key: 5939579
• MDR Text Key: 54337809
• Report Number: 2438477-2016-00043
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10257RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2016
• Distributor Facility Aware Date: 08/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1