MAUDE Adverse Event Report: DEVILBISS HEALTHCARE PLASTIC BATH TRANSFER BENCH ; ADAPTOER, HYGIENE

Model Number 12011KD-1

Device Problems Corroded (1131); Product Quality Problem (1506)

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

Event Date 06/22/2019

Event Type  No Answer Provided  

Event Description

My wife is disabled from a stroke and needs a bath transfer bench to shower.This bench requires two legs outside the tub and two legs inside the tub.My wife sits on the bench, moves her legs inside the tub and then slides over to shower.I assist her with this, and for many years, i used a bench manufactured by "drive medical" located in (b)(4).I never had an issue with this transfer bench.After many years of using the bench, on (b)(6) 2018, i purchased the exact same bench as a replacement.I purchased a transfer bench made by drive medical from (b)(6).The bench product code: 12011kd-1.Info on the frame reads: (b)(4).A product code on the frame reads: 5b1709016812.Recently, i noticed that the legs inside the tub began to rust.At first, the rust appeared where the bench legs attach to the rubber suction cups that keep the bench secure inside the tub when using.Then, i noticed that rust appeared where the legs attach to the bench seat at the frame joints.I found this very alarming and a definite safety issue.The thought of the seat or bench legs collapsing while helping my wife was very disturbing for me.On (b)(6) 2019, i logged on to the (b)(6) website.My (b)(6) order number was: (b)(6).Their return policy states 30 days.(b)(6) makes it very difficult to contact them directly.(b)(6) also states that "hygiene" products cannot be returned.I then contacted drive medical customer support via email.I took three (b)(6) photos showing the rusting areas and included them in my email.I also explained the circumstances of when i purchased the item and the safety concerns i had using it with my wife.I received the below response.Purchase date: (b)(6) 2019.(b)(4).

• Brand Name: PLASTIC BATH TRANSFER BENCH
• Type of Device: ADAPTOER, HYGIENE
• Manufacturer (Section D): DEVILBISS HEALTHCARE
• MDR Report Key: 8785868
• MDR Text Key: 151299841
• Report Number: MW5088068
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 12011KD-1
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR