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

Model Number	GV974HD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952)
Date of Event	11/22/2022
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, who stated that he was sitting on the rollator when "the back support suddenly broke (support screw dislodged)." the end user reported that he was "thrown to the floor," sustaining a sprained elbow and spine ligament, and sought medical treatment as a result of the incident.Multiple attempts to gather further information have been made, and to retrieve the product for evaluation, but drive has not received a 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: 16788012
• Report Number: 2438477-2022-00143
• Device Sequence Number: 12143232
• Product Code: ITJ
• UDI-Device Identifier: 00822383582245
• UDI-Public: 822383582245
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 04/21/2023
• Report Date (Section F): 04/21/2023

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: GV974HD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2022
• Device Age: 4 YR
• Date Report to Manufacturer: 04/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• 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: Other
• Patient Sex: Male
• Patient Weight: 114 KG
• Date Report Sent to FDA: 04/21/2023