MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; LOCKING ELEVATED TOILET SEAT

Catalog Number MDS80314MB

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

The end user reported that while sitting on the device, the seat detached from the toilet and she fell.She was evaluated in the er and diagnosed with a compression fracture in her neck.She states she did not install the device on her toilet.The sample was returned and evaluated.There were no fractures, dents or abnormalities present.The threaded knob to lock the toilet seat did not display any signs of stripping.The knob was able to securely lock the device in place.It is unknown if the raised toilet seat was properly installed onto the toilet.The owner's manual instructs the user to ensure all attaching hardware is securely tightened prior to use.No manufacturing defect was identified during the sample evaluation.We cannot rule out improper installation as a potential root cause for the reported incident.

Event Description

The end user fell while using the device and suffered a compression fracture in her neck.

• Type of Device: LOCKING ELEVATED TOILET SEAT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5960607
• MDR Text Key: 55063616
• Report Number: 1417592-2016-00097
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS80314MB
• Device Lot Number: 88515110024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 52