MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT LTD CO DRIVE; ROLLATOR

Model Number 10257BL-1

Device Problem Unintended Movement (3026)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 08/17/2021

Event Type  Injury  

Event Description

(b)(6) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.It is six years old.We are filing this report in an overabundance of caution and to be timely.A follow-up report will be submitted when additional information is acquired.Initial report stated that end-user was sitting on his device and the seating pad broke.He fell on the cement and we had to take him to the er.Subsequent report stated that the end-user was sitting on the device in his yard.He reported that the brakes suddenly failed and his device spun around multiple times.He fell to the pavement and was taken to the emergency room.X-rays detected no broken bone.He was scraped up and given tylenol for the pain.His caregiver stated that he is in physical and occupational therapy and requires a nurse attendant.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT LTD CO; liaoan village,; wanshi town; fuyang district, hangzhou city zhejiang 31140 6; CH 311406
• MDR Report Key: 12465102
• MDR Text Key: 271907054
• Report Number: 2438477-2021-00044
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/13/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 10257BL-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Distributor Facility Aware Date: 08/17/2021
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 09/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 57