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

Model Number	R800BL
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's daughter, who stated that her mother "sat down in the rollator and her hand went down on side and was cut on the sharp edge of the screw." the end user required five stitches.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
• Common Device Name: 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: 17166620
• Report Number: 2438477-2023-00082
• Device Sequence Number: 5421839
• Product Code: ITJ
• UDI-Device Identifier: 00822383524108
• UDI-Public: 822383524108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2023
• Report Date (Section F): 06/20/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: R800BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2023
• Device Age: 6 YR
• Date Report to Manufacturer: 06/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 06/20/2023