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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE MEDICAL DRIVE MOBILITY WALKER

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DRIVE MEDICAL DRIVE MOBILITY WALKER Back to Search Results
Device Problems Fail-Safe Problem (2936); Protective Measures Problem (3015)
Patient Problems Bruise/Contusion (1754); Edema (1820); Fall (1848); Head Injury (1879); Thrombus (2101); Ulceration (2116); Disability (2371); Fluid Discharge (2686)
Event Date 04/28/2015
Event Type  Injury  
Event Description
On (b)(6) 2015, my mother was thrown head first onto a hard concrete floor as a result of her drive medical walker malfunctioning.In addition to a multitude of massive bruises all over her body.She also had to get 15 stitches to close up the front of her forehead "that split wide open" from this fall and then just weeks later - my mother now moved on to develop two life threatening blood clots in her left leg from the physical trauma that she sustained! i will be seeking legal advice on behalf of my (b)(6) mother, but in the meantime, i want to save others from the horror of this same fate! please make the manufacturer post warning signs on their walkers as they do pose "a life-threatening trip-hazard" that none of us were ever made aware of! according to health day news, each year there are more than 47,000 elderly people who are treated at hospital emergency departments for injuries from falls that involve walkers and canes.That works out to 129 injuries per day.Walkers were associated with seven times as many injuries as canes.Walkers accounted for 87.3 percent of these injuries.But what's even worse is that 25 percent "all died within a year" of sustaining these injuries! someone has to do something about this! that's 11,750 people we are losing each year! and for those who survived - it is equally as important that we look at how the quality of their life has changed.For the elderly who fall and are unable to get up on their own - the period of time spent immobile often affects their health income.Muscle cell breakdown starts to occur within 30-60 minutes of compression due to falling.Dehydration, pressure sores, hypothermia, arthritis, and pneumonia are often complications that can arise - and in my mother's case - they can now add severe fluid retention (edema) and increased incidence of leg ulcerations, not to mention the danger of infection, the potential risk of ever losing a limb and the risk of death from these blood clots she just got.Older woman, like my mom, most often were the victims of these falls and while this fall not only just robbed my mother of the independence she once had, it further altered all of our lives - for we are now up "around the clock" after frightfully seeing how that walker almost killed her! falls associated with walking aids is a under-recognized public health problem that needs to be properly addressed for the sake of public safety - for the sake of saving lives! my mother literally has water pouring out of legs from not being able to walk around as much as she needs to and as a result of such - she has further been back and forth to the doctors every single week to have casts put on her leaking legs! this is truly horrifying.No one should ever be put through something like this.Injuries and hospital admission for falls associated with walking aids are self-evident in itself that research is needed to improve the design of these walking aids to reduce the risk of these potentially life-threatening injuries from occurring.These walkers are unsafe and our people need to be warned about them.Over 20 billion dollars each year is being spent for the treatment of these injuries - and yet despite what's happening - no one is doing anything about it.Its up to us to make that change.Its up to us to show we care.Most compassionately, (b)(6).
 
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Brand Name
DRIVE MOBILITY WALKER
Type of Device
DRIVE MOBILITY WALKER
Manufacturer (Section D)
DRIVE MEDICAL
MDR Report Key4993087
MDR Text Key25261990
Report NumberMW5055277
Device Sequence Number1
Product Code ITJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/03/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age87 YR
Patient Weight60
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