MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP DRIVE; ROLLATOR

Model Number R800KD-BL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 05/14/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of a complaint involving a rollator by an end user, stating that "the wheel brake lever sticks out too much - about an inch past the wheel and is causing her to hit her ankles and be cut." urgent care referred her to the wound care center and she is being treated for these injuries.States she had to have 11 stitches in her right ankle.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): HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP; liaoan village; wanshi town, fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 17761355
• MDR Text Key: 323577134
• Report Number: 2438477-2023-00125
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 822383004228
• 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: 09/15/2023

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: R800KD-BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 75 KG