MAUDE Adverse Event Report: CHANG CHENG FA ENTERPRISE CO., LIMITED DRIVE; ROLLATOR

Model Number	GV974RD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's physical therapist, who reported that the "right front tire's bearing came out and the tire dislodged from the mounting track on the walker while in use," and that "as a result the [end user] fell." there was no report or medical treatment associated with the complaint.Multiple attempts were made to retrieve the product for investigation, with no response.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA ENTERPRISE CO., LIMITED; no. 1 been ting; been-tsuoh village; chia-yi shiann shi-koou shiang, chiayi ; TW
• MDR Report Key: 17140159
• Report Number: 2438477-2023-00068
• Device Sequence Number: 5781866
• Product Code: ITJ
• UDI-Device Identifier: 00822383964140
• UDI-Public: 00822383964140
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023
• Report Date (Section F): 06/15/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: GV974RD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2023
• Date Report to Manufacturer: 06/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• 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; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/15/2023