MAUDE Adverse Event Report: BARIATRIC STEEL ROLLATOR WALKER; WALKER MECHANICAL

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/11/2018

Event Type  No Answer Provided  

Event Description

To whom it may concern; the reason i am writing to your agency is in hope to request you assistance in a very important matter.Al this time i am suffering with a host of physical conditions and fighting to receive adequate medical care.I was recently prescribed a bariatric steel rollator walker.However two weeks after receiving the walker, the right wheel was close to falling off.I immediately informed the medical dept the condition the walker was in.The walker came with a lifetime limited warranty.I informed the medical dept that i wanted to return the device and would like a full refund.I was refused.I have copies of the warranty and a document that came from the medical dept (mrs (b)(4)) responding that the company / mfr "drive" stating that they said that they would not issue me a refund.However i was under the impression that as a consumer i had the right to exercise my warranty.Never-the-less i was forced to have the device repaired at my expense.If your agency needs copies of the said document along with a copy of the warranty, please contact me and i will be more than glad to send them to you.I came in hopes that your agency can step in and help me.

• Brand Name: BARIATRIC STEEL ROLLATOR WALKER
• Type of Device: WALKER MECHANICAL
• MDR Report Key: 8000040
• MDR Text Key: 125341510
• Report Number: MW5080799
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1