MAUDE Adverse Event Report:; ROLLATOR

Device Problem Crack (1135)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

End-user called in (b)(6) 2018 - he received a rollator from a hospital in (b)(6) (did not provide a date).End-user mentioned he was just released from the hospital for two minor strokes within the past week.The backrest on his rollator cracked, and he flipped upside down and hit his head.User was admitted to the hospital for three days.It's not clear what injuries were sustained, and if any treatment was provided.User did receive an mri.He otherwise got very upset when asked for further information & hung up.Location where this event occurred is unknown, as user also did not provide this information.Part number, serial number, & supplier information on the rollator involved in this event was not provided.

• Type of Device: ROLLATOR
• MDR Report Key: 8139806
• MDR Text Key: 129589332
• Report Number: 3012316249-2018-00059
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2018
• Distributor Facility Aware Date: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention