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

Model Number	R726BL
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Concussion (2192)
Date of Event	12/19/2019
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 been returned for evaluation.End-user was tired and went to sit on the rollator.It was reportedly locked but moved t from under him.He fell on his left arm and hit his head.He sustained a concussion from the fall.He reportedly has tears between the incoustal space of his ribs on his left side.He suffered abrasions on his lower leg where he hit the concrete.He went to the hospital the same day.He is currently on bed rest.He is already being treated at a pain clinic.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; 1, chuangye st sw industrial; matou ecological industry park; handan city hebei,, 05604 6; CH 056046
• MDR Report Key: 9607308
• Report Number: 2438477-2020-00004
• Device Sequence Number: 14133439
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: 822383233208
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/20/2020
• Report Date (Section F): 01/20/2020

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: R726BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/20/2019
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2020
• 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
• Date Report Sent to FDA: 01/20/2020