MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	10215RD-1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device was not recovered for evaluation.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The consumer was sitting on the walker sweeping with his broom when the wheel snapped.He fell, hit his head, and went to the doctor.He received no serious injuries.Historical data for complaints of this issue were very limited.Defect rate was (b)(4) the unit was in use for 2 years with no maintenance.The consumer was not following the instructions for use.The device is not a transport chair.Brakes should be engaged while seated with no motion permitted.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10466094
• Report Number: 2438477-2018-00079
• Device Sequence Number: 14095159
• Product Code: ITJ
• UDI-Device Identifier: 00822383100654
• UDI-Public: 822383100654
• 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): 08/28/2020
• Report Date (Section F): 08/28/2020

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: 10215RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2018
• Device Age: 2 YR
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 163
• Date Report Sent to FDA: 08/28/2020