MAUDE Adverse Event Report: DRIVE; ROLLATOR

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 07/15/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated "he uses this unit while seated to roll around his home," in direct contravention of both on-product warnings and warnings in the unit's instructions for use that specify that it is not to be used as a transport device.The end user stated that "he was going over the threshold of his kitchen while seated and rolling himself, toppled over backwards," causing the back rest to break.The end user "hit his head causing him to bleed," but did not seek any medical treatment.Drive informed the end user that the unit should not ever be used in this manner, as described in the on-product warnings and in the instructions for use.The end user stated he "will not be returning the unit." drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• MDR Report Key: 15615243
• MDR Text Key: 301833750
• Report Number: 2438477-2022-00107
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 10/17/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2022
• Distributor Facility Aware Date: 09/26/2022
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 100 KG