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

Model Number Z120

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Manufacturer Narrative

It is not clear why the toilet chair tipped because the client was not being supervised during use.The toilet chair was inspected by the distributor and no problem with the device was found.The product manual warns: "the portable base is intended for travel use only and should not be used as the primary base.Ensure adequate stability when using the portable base" "a qualified professional must assess the appropriateness and safety of all equipment for each user." "this product is intended for use by clients of unreliable judgment.Adult supervision is required at all times.".

Event Description

It was reported that while using the hygiene and toileting system seat with the portability base, the based tipped forward and the user impacted the floor, resulting in the loss of two teeth.

• Brand Name: RIFTON HYGIENE AND TOILETING SYSTEM
• Type of Device: TOILET SYSTEM
• Manufacturer (Section D): RIFTON EQUIPMENT; 100 spring valley road; farmington, pa
• Manufacturer (Section G): RIFTON EQUIPMENT; 100 spring valley road; farmington, pa
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, ny ; 6587722
• MDR Report Key: 10497944
• MDR Text Key: 205938083
• Report Number: 3010761454-2020-00001
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Z120
• Device Catalogue Number: Z120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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
• Patient Outcome(s): Disability
• Patient Weight: 20