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

Model Number	10257BL-1
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) healthcare is the initial importer of the device which is a rollator.We have not retrieved the device for evaluation.End-user is requesting compensation for (b)(4) bills.End-user was sitting on the device.When she got up the handgrip reportedly slipped completely forward.She went forward with the grip and hit the floor.She injured her right side and ankle.The fire department assisted her and brought her to the er.She was diagnosed with a broken ankle and fibula, given a boot and directed to see a specialist.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT LTD CO; liaoan village; wanshi town; fuyang district, 31140 6; CH 311406
• MDR Report Key: 9207701
• Report Number: 2438477-2019-00067
• Device Sequence Number: 3146611
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019
• Report Date (Section F): 10/18/2019

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: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2019
• Device Age: 3 YR
• Date Report to Manufacturer: 10/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• 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: 81 YR
• Patient Weight: 88
• Date Report Sent to FDA: 10/18/2019