MAUDE Adverse Event Report: RIFTON EQUIPMENT HYGIENE TOILETING SYSTEM (HTS); TOILET CHAIR

Model Number Z130

Device Problem Insufficient Information (3190)

Patient Problem Tooth Fracture (2428)

Event Date 03/06/2023

Event Type  Injury  

Event Description

It was reported that the backrest slid off the seat causing the user to fall out of the chair and chip her two front teeth.

• Brand Name: HYGIENE TOILETING SYSTEM (HTS)
• 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 12471 ; 8456587722
• MDR Report Key: 16684840
• MDR Text Key: 312727205
• Report Number: 3010761454-2023-00001
• 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: Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Z130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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 Age: 15 YR
• Patient Sex: Female
• Patient Weight: 61 KG