MAUDE Adverse Event Report: IN-STEP MOBILITY PRODUCTS, INC. U-STEP 2 WALKER

Device Problem Product Quality Problem (1506)

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

Event Date 01/22/2017

Event Type  No Answer Provided  

Event Description

U-step-2 walker: the seat covers a storage compartment and the front of the seat lifts to open.If the back of the seat is lifted accidentally instead of the front, the walker folds up.It is easy not to notice if the seat is not firmly down so that the walker can fold while the person is walking with it.A fall easily occurs.This is an extremely sturdy walker designed so that it only moves when calipers are squeezed, as opposed to rolling walkers that one must actively apply brakes.This only moves when caliper(s) is squeezed.It is good for those who have difficulty remembering to apply brakes when transferring (to chair) from walker.Product category" personal care.Product type: personal protection.Mfr website url: www.Ustep.Com.Mfr phone number: (b)(4).Purchase date: (b)(6) 2014.This date is an estimate.The product was damaged before the incident: no.The product was modified before the incident: no.Explanation: i had mentioned this to the designer at u step right after purchase and he felt it was not a defect.However, a safety latch to prevent accidental folding is necessary.Injury seen by medical professional.(b)(4).

• Brand Name: U-STEP 2 WALKER
• Type of Device: U-STEP 2 WALKER
• Manufacturer (Section D): IN-STEP MOBILITY PRODUCTS, INC.; 8048 monticello ave; skokie IL 60076
• MDR Report Key: 6307357
• MDR Text Key: 66880173
• Report Number: MW5067690
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/22/2017

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 95 YR