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

Model Number R800KD-RD

Device Problem Insufficient Information (3190)

Patient Problems Skin Infection (4544); Easy Bruising (4558)

Event Date 06/27/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who reported that "when [her mother] walks, the rollator is bumping against her legs, causing bruising.Also, when she stands up, she's bumping into the brakes, again eating her legs." the end user sought treatment in the emergency room, where it was determined that her legs were infected, and she was treated with antibiotics." the daughter reported that her mother's doctor "believes that the design of the rollator is not made for her body type." drive is currently investigating the incident and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT CO., LTD.; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 15315995
• MDR Text Key: 298858606
• Report Number: 2438477-2022-00083
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383004235
• UDI-Public: 822383004235
• 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: 08/29/2022

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 Model Number: R800KD-RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Home
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female