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

Model Number GV974HD

Device Problem Break (1069)

Patient Problems Fall (1848); Damage to Ligament(s) (1952)

Event Date 11/22/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 313749874
• Report Number: 2438477-2022-00143
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383582245
• UDI-Public: 822383582245
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: GV974HD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2023
• Distributor Facility Aware Date: 12/05/2022
• Device Age: 4 YR
• Date Report to Manufacturer: 04/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 114 KG