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

Model Number Z110

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2019

Event Type  malfunction  

Event Description

It was reported that the client was using the rifton toilet seat mounted to a toilet using the mounting bar.Once end of the mounting bar broke, and the child fell forward.The child reportedly received a minor cut on her forhead, but was otherwise not seriously 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: 9139223
• MDR Text Key: 193419136
• Report Number: 3010761454-2019-00001
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Z110
• Device Catalogue Number: Z110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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