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

Model Number R800BL

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event 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
• 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: 17166620
• MDR Text Key: 317537286
• Report Number: 2438477-2023-00082
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383524108
• UDI-Public: 822383524108
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: R800BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Distributor Facility Aware Date: 05/25/2023
• Device Age: 6 YR
• Date Report to Manufacturer: 06/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Sex: Female