MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9 DRIVE; ROLLATOR

Model Number	795BU
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a rollator.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.End-user has owned and used the product for two years.On two occasions when he went to sit on the device the unit "flipped" and he fell.Both times he hit his head.After initial contact the end-user agreed to return the unit for evaluation but did not send it to us.Further attempts to contact the end-user were unsuccessful.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9; 1 chuangye st sw indust dist.; matou eco. indust. pk.; handan city, hebei 05604 6; CH 056046
• MDR Report Key: 10046382
• Report Number: 2438477-2018-00063
• Device Sequence Number: 19656448
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 822383221649
• 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): 05/11/2020
• Report Date (Section F): 05/12/2020

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: 795BU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2018
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 05/12/2020