LEGGERO TRAK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-07 for LEGGERO TRAK manufactured by Leggero.

Event Text Entries

[85573859] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072010
MDR Report Key6848379
Date Received2017-09-07
Date of Report2017-08-13
Date of Event2017-08-12
Date Added to Maude2017-09-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLEGGERO TRAK
Generic NameADAPTIVE STROLLER
Product CodeINM
Date Received2017-09-07
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerLEGGERO


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-07

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