MAUDE Adverse Event Report: UNKNOWN DRIVE; BARIATRIC ROLLATOR

Model Number	10216BL-1
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bariatric rollator.The unit has not been returned for evaluation.End-user was injured when the rollator slid out from under him while he sat on its seat.The brakes reportedly failed to work while engaged.He suffered an l2 vertebrae compression fracture requiring surgical repair.

• Brand Name: DRIVE
• Common Device Name: BARIATRIC ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9643217
• Report Number: 2438477-2020-00006
• Device Sequence Number: 16689176
• Product Code: ITJ
• UDI-Device Identifier: 00822383265254
• UDI-Public: 822383265254
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/29/2020
• Report Date (Section F): 01/29/2020

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: 10216BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/09/2019
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2020
• 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: Required Intervention
• Date Report Sent to FDA: 01/29/2020