MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number 795B

Device Problem Material Frayed (1262)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 02/04/2022

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• MDR Report Key: 13683863
• MDR Text Key: 286844447
• Report Number: 2438477-2022-00014
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 795B
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Distributor Facility Aware Date: 02/07/2022
• Device Age: 1 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female