MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO LTD DRIVE; ROLLATOR

Model Number	RTL10261BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's daughter, who stated that the "leg frame was broken," which reportedly caused the end user to fall off and "hit his head on [a] counter." it is not clear whether the frame was broken during the reported incident, or before.The reporter confirmed that there was no illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's daughter, who stated that the "leg frame was broken," which reportedly caused the end user to fall off and "hit his head on [a] counter." it is not clear whether the frame was broken during the reported incident, or before.The reporter confirmed that there was no illness, injury or medical treatment associated with the complaint.Drive processed a replacement for the end user.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO LTD; no. 589 hualu road,; no.39, hengtong road; huashi town, jiangsu 21442 1; CH 214421
• MDR Report Key: 17087151
• Report Number: 2438477-2023-00062
• Device Sequence Number: 2805836
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/10/2023
• Report Date (Section F): 06/08/2023

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: RTL10261BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 06/15/2023
• 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: 06/08/2023
• Supplement Report FDA Received Date: 08/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Date Report Sent to FDA: 06/08/2023