MAUDE Adverse Event Report: RIFTON EQUIPMENT SUPPORT STATION; TOILET TRANSFER DEVICE

Model Number K710

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

The product is intended to be installed by the user.The product manual warns that a qualified professional, such as a building contractor or maintenance person, must securely install this product to the wall.

Event Description

It was reported that the support station, a toileting transfer device, fell off the wall while in use.

• Brand Name: SUPPORT STATION
• Type of Device: TOILET TRANSFER DEVICE
• 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: 14642771
• MDR Text Key: 300467505
• Report Number: 3010761454-2022-00002
• Device Sequence Number: 1
• Product Code: ILS
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: K710
• Device Catalogue Number: K710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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: 45 KG