MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number RTL10261RD

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 10/27/2021

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 will file a follow-up submission when additional data becomes available.The rollator was reported 5 years old.While in use the leg of the device snapped causing the end-user to fall aggravating an existing spinal injury.He is in severe pain and on pain medication.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12791821
• MDR Text Key: 283141121
• Report Number: 2438477-2021-00071
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 822383262772
• 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: 11/10/2021

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: RTL10261RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2021
• Distributor Facility Aware Date: 11/10/2021
• Device Age: 5 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG