MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON HYGIENE AND TOILETING SYSTEM; TOILET CHAIR

Model Number Z130

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter stated that they are not sure what actually happened.It is not clear whether the breakage was caused by the user possibly having a seizure, or if the mounting bar was incorrectly assembled or damaged prior to use.

Event Description

It was reported that the client was using the rifton toilet seat mounted to a toilet using the mounting bar.One end of the mounting bar broke, and the child fell off the toilet but was not injured.

• Brand Name: RIFTON HYGIENE AND TOILETING SYSTEM
• Type of Device: TOILET CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 100 spring valley road; farmington PA 15437
• Manufacturer (Section G): RIFTON EQUIPMENT; 100 spring valley road; farmington PA 15437
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 10953208
• MDR Text Key: 232568402
• Report Number: 3010761454-2020-00002
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z130
• Device Catalogue Number: Z130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1