MAUDE Adverse Event Report: JOBAR INTERNATIONAL, INC BIG WHEELS WALKER KIT; WALKER, MECHANICAL

Model Number JB7536 (040121)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2021

Event Type  Injury  

Event Description

I use a walker.I purchased a new set of wheels, off-road walker kit, from the company support plus.The first set was purchased in 2019 and within a year the wheel fell off.I was shopping in wholes foods.They were unable to find my missing hardware to fix the wheel so i had to take a taxi home.I purchased a second set from the same company and had the same problem.Again, i took a taxi home.I emailed support plus to complain and asked if they had a repair service.They referred me to the manufacturer, jobar international, inc.They informed me that they do not sell separate component pieces and that they did not have any spare parts in their warehouse.The customer service manager, (b)(6), suggested that i look online for a repair service.I have his emails.(b)(6).Reference report: mw5144762.

• Brand Name: BIG WHEELS WALKER KIT
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): JOBAR INTERNATIONAL, INC; 3112 kashiwa st; torrance CA 90505
• MDR Report Key: 17584226
• MDR Text Key: 321692175
• Report Number: MW5144761
• 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: 08/16/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JB7536 (040121)
• Device Catalogue Number: FF2412
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2023
• Patient Sequence Number: 1
• Treatment: WALKER.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American