MAUDE Adverse Event Report: WUXI KANGQIANG INDUSTRIAL EQUIPMENT DRIVE; ROLLATOR

Model Number	RTL10261BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is an adjustable height rollator.We have not received the device for evaluation.We have images of the damaged device for evaluation.The end-user was sitting on the device when the frame broke at the longest adjustment button.She was using the device every day for at least six months.She did not initially seek medical attention.After several days she sought medical attention and was reportedly diagnoses with a fractured right foot.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): WUXI KANGQIANG INDUSTRIAL EQUIPMENT; cangpu village; yicheng district; yixing, 21420 6; CH 214206
• MDR Report Key: 8420768
• Report Number: 2438477-2019-00005
• Device Sequence Number: 2242044
• Product Code: ITJ
• UDI-Device Identifier: 00822383262765
• UDI-Public: 822383262765
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2019
• Report Date (Section F): 03/14/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10261BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2019
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68
• Date Report Sent to FDA: 03/14/2019