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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PATTERSON MEDICAL SUPPLY DAYS ROLLATOR
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PATTERSON MEDICAL SUPPLY DAYS ROLLATOR Back to Search Results
Device Problems Collapse (1099); Device Unsafe to Use in Environment (2918)
Patient Problem Bone Fracture(s) (1870)
Event Type  Other  
Event Description
I am writing about a safety matter which concerns myself as well as other veterans and the general public.It involves a rollator manufactured in (b)(4) by "(b)(4)" and marketed in the us by (b)(4).I am concerned with their item 106, but the problem may not be limited to that item.On (b)(6) 2016, the (b)(6), provided me with a rollator (a wheeled walker) for my use.We both liked the product and i encouraged her to try it out.The next day, i happened to be in (b)(6) when my life sat in it to see if she wanted one like it for herself, however, it collapsed on her.My son, who was there at the moment, was able to untangle his mother and extricate her from the rollator and into her bed.As a result of the accident she could not stand, sit or walk for several months and was bed ridden.My son could not believe what had happened, and he sat in the rollator and it collapsed on him also, however, he was not injured.X-rays revealed a compression fracture of the no.1 lumbar vertebra.Later we were able to get her to the hospital for an mri which detailed the fracture.She then had a treatment wherein a cement was injected into the fracture and she was able to move around without pain.Of course, i brought this to the attention of the mfr, and requested compensation for medical bills and for her pain and suffering.The mfr hired a consulting engineer to examine the rollator and report back to them.The engineer agreed with me during his examination that the design had a safety problem.My wife's claim was denied by their insurance company stating that it was built according to specs and that the claim was not valid and that the accident must never have happened.I have performed failure analyses for companies such as (b)(4) and crash investigations for the (b)(4).I have been designing machinery for various companies for over thirty years and i am well aware of marginal designs.My wife has been a care giver for many years and is quite familiar with walkers.Wheelchairs and the like in her practice.Their current product is not designed with a suitable safety factor and should not be permitted to remain on the market especially available to my fellow veterans through the (b)(6).I will attach a photo of the rollator as provided to me.You will note that the safety straps sag which will permit the rollator to fold downward as well as upward.The design is for the user to pull up on a strap and fold the unit for transport.However, in this instance, the collapse was due to the straps being below center.One of the straps has a flange formed in it, but it is only 1/16th inch and as such allows the strap to pass center downward.I modified the unit supplied to me with aluminum angle preventing downward closing and permitting only upward action and then only when the safety tubing is retracted.I am comfortable in its safety.I urge you to support me in preventing further purchases by the (b)(4) until the design is changed to include similar safety for our veterans.Photo of rollator as received; photo of rollator as modified for safety which prevents upward as well as downward fold; photo of rollator with safety tube retracted for fold up; (b)(6).
 
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Brand Name
DAYS ROLLATOR
Type of Device
DAYS ROLLATOR
Manufacturer (Section D)
PATTERSON MEDICAL SUPPLY
MDR Report Key5748644
MDR Text Key48531500
Report NumberMW5063019
Device Sequence Number1
Product Code ITJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/22/2016
Type of Device Usage N
Patient Sequence Number1
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