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

Model Number	R800BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device was not in use during the incident.It will not be retrieved for evaluation.The end-user was getting up from bed.Reaching for the walker.Her leg came down on the walker and she was cut by the brake cable.She sought medical attention and is currently going to wound clinic for care.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang, 31140 6; CH 311406
• MDR Report Key: 10578065
• Report Number: 2438477-2020-00047
• Device Sequence Number: 2627852
• Product Code: ITJ
• UDI-Device Identifier: 00822383524108
• UDI-Public: 822383524108
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2020
• Report Date (Section F): 09/23/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: R800BL
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2020
• Device Age: 45 MO
• Event Location: Home
• Date Report to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 61
• Date Report Sent to FDA: 09/23/2020