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

Model Number R726BL

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Concussion (2192)

Event Date 12/19/2019

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 176298792
• Report Number: 2438477-2020-00004
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: 822383233208
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R726BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2020
• Distributor Facility Aware Date: 12/20/2019
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 01/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization