MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	R726BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a rollator.The device is not available for inspection.No images requested have been received.We are filing this report in an over abundance of caution.End-user was reaching out to grab the device when it collapsed on her.She fell bruising her elbow, leg, and ear.She received a bump on her head.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10082626
• Report Number: 2438477-2020-00029
• Device Sequence Number: 2861729
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: 822383233208
• 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): 05/22/2020
• Report Date (Section F): 05/22/2020

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: 05/14/2020
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2020
• 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: Disability
• Patient Age: 86 YR
• Patient Weight: 45
• Date Report Sent to FDA: 05/22/2020