DRIVE R900RD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for DRIVE R900RD manufactured by Hangzhou Fuyang Hongwei Metal Product Limited Comp.

Event Text Entries

[184253017] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2438477-2020-00010
• MDR Report Key: 9728559
• Date Received: 2020-02-19
• Date of Report: 2020-01-22
• Date of Event: 2019-12-25
• Date Facility Aware: 2020-01-02
• Report Date: 2020-02-11
• Date Reported to FDA: 2020-02-11
• Date Reported to Mfgr: 2020-02-11
• Date Added to Maude: 2020-02-19
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRIVE
• Generic Name: ROLLATOR
• Product Code: ITJ
• Date Received: 2020-02-19
• Model Number: R900RD
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 16 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP
• Manufacturer Address: LIAOAN VILLAGE, WANSHI TOWN FUYANG DISTRICT HANGZHOU CITY, ZHEJIANG, 311406 CH 311406

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2020-02-19