MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	795B
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, drive devilbiss healthcare was notified of an incident involving a rollator.The end user's daughter reported that "the brake cable was frayed and broken," and that her mother fell while using the rollator, causing her to go to the hospital, where she was diagnosed with "bumps and bruises on her forehead," but no broken bones.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it, and will update this report if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 13683863
• Report Number: 2438477-2022-00014
• Device Sequence Number: 11865885
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• Combination Product (Y/N): N
• 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): 03/07/2022
• Report Date (Section F): 03/07/2022

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: 795B
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2022
• Device Age: 1 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2022
• 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 Sex: Female
• Date Report Sent to FDA: 03/07/2022