MAUDE Adverse Event Report: WUXI KANGQIANG INDUSTRIAL DRIVE; ROLLATOR

Model Number	RTL10261RD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of in incident involving a rollator by an end user's daughter, who stated that she "stood up from [her] chair, took a step and it broke." there was no information provided regarding the exact nature of the break.The end user reportedly fell, causing a "knot on her hip" and required an ambulance to assist her.She is currently taking pain medication and receiving physical therapy.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated that she "stood up from [her] chair, took a step with [the rollator] and it broke." the end user reportedly fell, causing a "knot on her hip" and required an ambulance to assist her.She is currently taking pain medication and receiving physical therapy.Drive requested that the unit be returned for investigation, during which it was noted that the rollator showed signs of extreme wear and tear, and it could not be determined whether the break in the leg occurred as a result of and the leg gave out after extended use.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): WUXI KANGQIANG INDUSTRIAL; 145 yipu road; dapu industrial park; yixing,, jiangsu 21420 6; CH 214206
• MDR Report Key: 17320692
• Report Number: 2438477-2023-00091
• Device Sequence Number: 6913073
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 822383262772
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023
• Report Date (Section F): 08/18/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10261RD
• Device Catalogue Number: RTL10261RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 7 YR
• Date Report to Manufacturer: 08/18/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/18/2023
• 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: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 08/18/2023