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

Model Number	R726RD
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/19/2016
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 was sitting on the device at work when the black metal / plastic strap broke and sfe fell backwards.She sustained an injury to her head, back, elbow and left hip.She went out on disability.She was treated for her injuries.We received photos of the device.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; 1 chuangye st; sw industrial dist.; matou eco. ind. pk., handan hebei 05604 6; CH 056046
• MDR Report Key: 10029028
• Report Number: 2438477-2016-00067
• Device Sequence Number: 16335127
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2020
• Report Date (Section F): 05/06/2020

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: R726RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/18/2017
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/06/2020