MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COM. 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	08/15/2019
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 unit has not been returned for evaluation.End-user got up to go to the bathroom in the middle of the night in the dark and when she got to her rollator.She felt a pinch on her leg.She walked to the bathroom and when she turned the light on she saw that she was bleeding profusely from her leg.She was able to wrap it up but the next day went to her doctor to get it checked out.The doctor recommended she go see a would care specialist who she saw a few days later and has been seeing weekly since.End-user states the brake pad that poked through her skin severed a blood vessel.However, the brakes are hand brakes.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COM.; liaoan village, wanshi town; fuyang district; hangzhou city, 31140 6; CH 311406
• MDR Report Key: 9440931
• Report Number: 2438477-2019-00079
• Device Sequence Number: 11794891
• Product Code: ITJ
• UDI-Device Identifier: 00822383524108
• UDI-Public: 822383524108
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019
• Report Date (Section F): 12/09/2019

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/06/2019
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2019
• 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: 87 YR
• Patient Weight: 34
• Date Report Sent to FDA: 12/09/2019