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

Model Number	R900RD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	12/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a rollator.The device has not be retrieved for evaluation.The end-user was using the device to get to the rest room at approximately 1am.The loop part on the brake broke and she fell.She hit her head and was bleeding.She went to the hospital.She does not remember what happened.As of the conversation with post market she was still in the hospital.According to her spouse she has been falling a lot lately.

• 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, zhejiang, 31140 6; CH 311406
• MDR Report Key: 9728559
• Report Number: 2438477-2020-00010
• Device Sequence Number: 2139277
• Product Code: ITJ
• UDI-Device Identifier: 00822383548593
• UDI-Public: 822383548593
• Combination Product (Y/N): N
• 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): 01/22/2020
• Report Date (Section F): 02/11/2020

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: R900RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/02/2020
• Device Age: 16 MO
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2020
• 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: Hospitalization
• Patient Age: 79 YR
• Patient Weight: 73
• Date Report Sent to FDA: 02/11/2020