MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	700-961
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/25/2020
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 has not been recovered for evaluation.A follow-up report will be submitted, once there is additional information available.While in use the fork assembly detached from the frame.The user fell, and hit her head.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10906339
• Report Number: 2438477-2020-00060
• Device Sequence Number: 2881908
• Product Code: ITJ
• UDI-Device Identifier: 00754021210893
• UDI-Public: 754021210893
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2020
• Report Date (Section F): 11/25/2020

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: 700-961
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 91
• Date Report Sent to FDA: 11/25/2020