MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	RTL10261RD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will file a follow-up submission when additional data becomes available.The rollator was reported 5 years old.While in use the leg of the device snapped causing the end-user to fall aggravating an existing spinal injury.He is in severe pain and on pain medication.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12791821
• Report Number: 2438477-2021-00071
• Device Sequence Number: 17448777
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 822383262772
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/10/2021
• Report Date (Section F): 11/10/2021

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: RTL10261RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2021
• Device Age: 5 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2021
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Date Report Sent to FDA: 11/10/2021