MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	RTL10261RD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.We have not received the device for evaluation.End-user purchased the device a few years ago.He was using the unit normally around the house.On this occasion the device frame snapped.He had surgery on 9/27 and received 9 screws and a metal plate in his leg.He has physical therapy.He must remain non weight bearing.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9312719
• Report Number: 2438477-2019-00075
• Device Sequence Number: 2360696
• 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
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2019
• Report Date (Section F): 11/12/2019

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2019
• 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
• Patient Age: 42 YR
• Patient Weight: 113
• Date Report Sent to FDA: 11/12/2019