MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number RTL199

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 07/12/2021

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an overabundance of caution to be timely.We will submit a follow-up once additional data is received.The device was loaned to a friend who fell and broke her hip.The owner of the device said the device was not the cause of the incident.The user slipped and fell.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12248541
• MDR Text Key: 265600294
• Report Number: 2438477-2021-00033
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383000701
• UDI-Public: 822383000701
• 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: 07/29/2021

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: RTL199
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Distributor Facility Aware Date: 07/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other