MAUDE Adverse Event Report: CAREX; TOILET SEAT ELEVATOR

Model Number FGB31600 0000

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Type  Injury  

Event Description

The end-user went to use the toilet seat elevator for the first time, and one of the handles broke off - the user fell.He leaned on the handle, and then he fell.911 came out to help him up & check him out.He has no broken bones, but does have some bruising.The user is reported as having not been supervised or assisted at the time of the malfunction, but the device's snap buttons are reported as having been securely locked in position.

• Brand Name: CAREX
• Type of Device: TOILET SEAT ELEVATOR
• MDR Report Key: 6856460
• MDR Text Key: 85740197
• Report Number: 3012316249-2017-00115
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGB31600 0000
• Device Catalogue Number: B316-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2017
• Distributor Facility Aware Date: 08/13/2017
• Event Location: Home
• 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
• Patient Age: 95 YR
• Patient Weight: 75