THE SHUTTLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for THE SHUTTLE manufactured by Unk.

Event Text Entries

[48019057] I was at physical therapy on (b)(6) for muscle strengthening of my left leg to help with a meniscus tear in the attain knee. I was using a machine known as the shuttle. The machine is basically a horizontal leg press. There is a place for your butt with handles a little lower than the butt rest and a head rest. There is a stationary foot platform that is about 3 feet by 3 feet. You lay down on the machine and your knees are at about a 90 degree angle. You push your feet against the platform and that makes the seat and head rest slide away from the foot rest. You keep pushing until right before your knees lock and then slowly bend your knees to slide back toward the platform and return your knees to the 90 degree angle. There is no mechanism to immobilize the butt rest and no stationary handles to use to get on and off the piece of equipment. In order to get off the machine, i hooked my left foot under the platform and pulled myself up toward the platform and grabbed it and then held onto it and pushed myself over the horizontal bar with the seat and headrest. I don't think a piece of physical therapy equipment should have a seat that you cannot stop from moving or no stationary handles to help you get on and off the machine. I severely bruised the top of my left foot, around and up, most of the toes were purple for over 2 weeks and there was a lump (which has mostly receded) on the top of the foot. I don't know if the severity of pulling myself up with the bad leg or pushing off it to get my leg over the machine caused my left knee to have severe pain, but i now have tremendous pain when i try to walk. I am using a knee wrap and cane to hobble around. The physical therapist told me i should have asked her to help me off. I didn't think it was safe to have a (b)(6) person try to help a (b)(6) person to get off a machine with all moving parts and nothing stationary for her or i to hold onto. Plus my legs would be at a 90 degree angle while doing so. The next time i was at physical therapy, a different therapist told me the machine was very old and had handles but the handles kept falling off so they leave them off. I don't know what kind of handles she was talking about.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062952
MDR Report Key5741230
Date Received2016-06-17
Date of Report2016-06-17
Date of Event2016-05-31
Date Added to Maude2016-06-22
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTHE SHUTTLE
Generic NameEXERCISER
Product CodeBXB
Date Received2016-06-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2016-06-17

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