Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAISED TOILET SEAT - RETAIL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RAISED TOILET SEAT - RETAIL Back to Search Results
Model Number FGB31000 0000
Device Problems Unstable (1667); Unintended Movement (3026)
Patient Problems Fall (1848); Hip Fracture (2349)
Event Date 02/28/2015
Event Type  Injury  
Event Description
Per communication from law firm, at approximately 7 am on (b)(6) 2015, the user went to the restroom - when he sat on the "handicapped" toilet, he went to put his coffee cup on the floor, but as he leaned over, the seat lifted and dumped him onto the floor.He yelled for his wife to come help him because he could not feel his hip.The end-user's wife called the front desk and told them what happened, and they called 911.The end-user was transported to a hospital, where he was put on morphine and, later that afternoon, had surgery to repair the hip fracture he sustained due to this fall.The user was in the hospital after the surgery.It is reported that the raised toilet seat was installed per the manufacturer's instructions.No serial number provided - cannot properly identify supplier.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RAISED TOILET SEAT - RETAIL
Type of Device
RAISED TOILET SEAT
MDR Report Key6190173
MDR Text Key62851105
Report Number3012316249-2016-00016
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFGB31000 0000
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2016
Distributor Facility Aware Date03/16/2016
Event Location Other
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-