MAUDE Adverse Event Report: WUXI KANGQIANG INDUSTRIAL DRIVE; ROLLATOR

Model Number RTL10261BL

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated that he "fell over while sitting on the unit" and reportedly scraped his head, elbow and knee.The end user reports that he did not seek any medical attention and claims that the leg of his rollator has broken.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): WUXI KANGQIANG INDUSTRIAL; 145 yipu road; dapu industrial park; yixing,, jiangsu 21420 6; CH 214206
• MDR Report Key: 17451877
• MDR Text Key: 320376520
• Report Number: 2438477-2023-00111
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383262765
• UDI-Public: 00822383262765
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL10261BL
• Device Catalogue Number: RTL10261BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2023
• Distributor Facility Aware Date: 07/05/2023
• Device Age: 5 YR
• Date Report to Manufacturer: 08/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female