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

Model Number	R800BK
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of this device which is a rollator.The claim is ongoing.As such, unit will not be returned until it is settled.The end user fell on two (2) occasions.The first time, she was sitting down, engaged the breaks, got up, and fell backwards.She hit head on the night stand and knee on the floor.The second time, she walking when she engaged the breaks.She reached for the rollator after and it slipped out from under her.She fell and could not get up, and hit her elbow.Her daughter and husband came and helped her up.She went to the hospital where x-rays were taken.She had no broken bones but stitches were needed for her elbow, foot black and blue.She got an mri, and got similar results.

• 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, 31140 6; CH 311406
• MDR Report Key: 8942565
• Report Number: 2438411-2019-00060
• Device Sequence Number: 14099445
• Product Code: ITJ
• UDI-Device Identifier: 00822383548579
• UDI-Public: 822383548579
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/28/2019
• Report Date (Section F): 08/28/2019

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: R800BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2019
• Device Age: 8 MO
• Date Report to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2019
• 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: 80 YR
• Patient Weight: 102
• Date Report Sent to FDA: 08/28/2019