MAUDE Adverse Event Report: CHANG CHENG FA ENTERPRISE CO., LIMITED9 DRIVE; ROLLATOR

Model Number	GV974HD-BR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.The end user sat on the device.The rear left wheel of the product reportedly detached and he fell backwards he was unconscious for about 20 minutes.He ended up being diagnosed with a fractured t7 vertebra.A procedure called a kyphoplasty was recommended but he elected not to undergo surgery at this time and is instead just treating with pt.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA ENTERPRISE CO., LIMITED9; no. 1 been ting, been-tsuoh vi; chia-yi shiann; shi-koou shiang, chiayi - district ; TW
• MDR Report Key: 9728741
• Report Number: 2438477-2020-00011
• Device Sequence Number: 19367829
• Product Code: ITJ
• UDI-Device Identifier: 00822383582245
• UDI-Public: 822383582245
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2020
• Report Date (Section F): 02/19/2020

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: GV974HD-BR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/19/2002
• Device Age: 14 MO
• Date Report to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2020
• 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
• Date Report Sent to FDA: 02/19/2020