MAUDE Adverse Event Report: LEGGERO LEGGERO TRAK; ADAPTIVE STROLLER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Injury (2348)

Event Date 08/12/2017

Event Type  No Answer Provided  

Event Description

My health insurance ((b)(6)) purchased a stroller designed for special needs children, a leggero trak stroller for children up to 80lbs.The design is flawed or it may be that the parts that make a safe are not standard in purchase which it should be.The leggero trak that we received, when my daughter moved her hips forward, she slid downwards quickly, despite the fact that she was secured properly in the straps as instructed by the supplier, and slipped off the seat and her body was off the seat and she strangled herself on the neck of the chest piece.It took me long enough to release the straps that she started to turn blue and had bruises on her neck.Also, the bottom straps of the butter chest barnes attached to the buckles on the frame of the stroller slid off and no longer were attached to the frame made her no longer be attached at the bottom which made her be completely unattached and slid off to the point that her lower half was unsecured and she strangled herself on the upper part! this is a piece of equipment specifically designed for children like mine! the seat needs to be contoured to where the bottom is slightly lower than the knees in positioning like a car seat and the lap belt needs to have a three-point harness that secures on the crotch and hips as standard and the buckles on the butterfly harness needs to be suckers in a secure manner as standard and, maybe a pommel.My child could have died! this is unacceptable especially when there is no warning to discourage children who hip thrust or move their hips at all and it is designed for children.I have emailed the supplier and they said "maybe the stroller isn't for your child" but i cannot return a piece of medical equipment once paid for by insurance and received.There was no warning and it was marketed as for children with special needs.Document number: (b)(4).Report number: (b)(4).

• Brand Name: LEGGERO TRAK
• Type of Device: ADAPTIVE STROLLER
• Manufacturer (Section D): LEGGERO
• MDR Report Key: 6848379
• MDR Text Key: 85573859
• Report Number: MW5072010
• Device Sequence Number: 1
• Product Code: INM
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR