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

Model Number	GV974HD-BR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Nora revision: drive devilbiss healthcare was notified by a distributor of an incident involving a rollator, in which an attorney stated that the end user reportedly fell due to a "defective plastic piece that is to attach to the backrest." the end user reportedly hit his neck and back, for which he sought medical attention.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.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA ENTERPRISE CO., LIMITED; no. 1 been ting, been-tsuoh; chia-yi shiann; shi-koou shiang, chiayi ; TW
• MDR Report Key: 15457065
• Report Number: 2438477-2022-00073
• Device Sequence Number: 12473111
• Product Code: ITJ
• UDI-Device Identifier: 00822383582245
• UDI-Public: 00822383582245
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2022
• Report Date (Section F): 09/20/2022

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
• Device Model Number: GV974HD-BR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2022
• Device Age: 1 YR
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/20/2022