MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	RTL10289RD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a rollator.The end-user discarded two units.Both units were discarded making us unable to perform an evaluation.The caregiver advised that the end-user had two of these devices and both units the bolt broke in half leaving part of the bolt in the stem while, she was walking with the unit.Both times she reportedly fell.In one instance the end-user went doctor several times.In the second instance was taken to the er and then for follow up treatment at her primary care doctor.She hit her nose on the concrete and hurt her right leg, which got infected.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9384732
• Report Number: 2438477-2019-00076
• Device Sequence Number: 14007993
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 822383259338
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/27/2019
• Report Date (Section F): 11/27/2019

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: RTL10289RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2019
• 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: Hospitalization
• Patient Age: 79 YR
• Date Report Sent to FDA: 11/27/2019