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

Model Number GV974HD

Device Problem Break (1069)

Patient Problems Fall (1848); Vertebral Fracture (4520)

Event Date 03/27/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated that the "backrest broke, and he fell and broke his back, sprained his wrists, lower back, and right knee." he did not provide any further information about how the rollator was being used at the time of the incident.The end user was reportedly taken to the hospital by ambulance to treat his injuries.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
• 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: 16771424
• MDR Text Key: 313604737
• Report Number: 2438477-2023-00032
• 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: 04/19/2023

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: 04/19/2023
• Distributor Facility Aware Date: 03/31/2023
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 04/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 124 KG