MAUDE Adverse Event Report: RIFTON EQUIPMENT E808 LARGE TOILET SYSTEM; TOILET CHAIR

Model Number E808

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

It was reported that the user was on the toilet seat when one side of the seat detached and the user fell to the floor.

Manufacturer Narrative

The caregiver reported that nothing on the toilet seat was broken, and that the user does not jerk or seize.We can only conclude that the seat was not installed properly on the toilet.

• Brand Name: E808 LARGE TOILET SYSTEM
• Type of Device: TOILET CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; elka park NY
• Manufacturer Contact: travis scott ; 2032 rt 213; rifton, NY 12471 ; 8456587722
• MDR Report Key: 4821547
• MDR Text Key: 19444433
• Report Number: 1319558-2015-00004
• Device Sequence Number: 1
• Product Code: INN
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 50