MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON BATH CHAIR

Model Number E542

Device Problem Device Contaminated at the User Facility (4064)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Although the bacteria responsible for the infection was found on the bath chair, it may have also been present in other areas of the bathroom that were not properly cleaned, or on other equipment the client uses.It is not clear that the chair is the sole source of the bacteria.

Event Description

It was reported that the user contracted repeated infections of a bacteria which was found, among other places, in the joints of the user's bath chair.It was suggested by the user's mother that bacteria harbored in chair joints may have been a source of the infection, which reoccurred even after thorough cleaning of the bath chair and the bathroom area.

• Brand Name: RIFTON BATH CHAIR
• Type of Device: BATH CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 2255 platte clove rd.; elka park NY 12427
• Manufacturer (Section G): RIFTON EQUIPMENT; 2255 platte clove rd.; elka park NY 12427
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 10766134
• MDR Text Key: 216630881
• Report Number: 1319558-2020-00014
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: E542
• Device Catalogue Number: E542
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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): Hospitalization