GENESIS FULL SHELL WALKER BOOT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-19 for GENESIS FULL SHELL WALKER BOOT manufactured by Medical Technology, Dba Bledsoebrace.

Event Text Entries

[29838721] Re: "full shell walker boot" made by medical technology inc. , d/b/a bledsoe brace systems. Facility that sold me the bledsoe walking boot: (b)(6). Primary issue: - inflatable air bladders in the boot are too small to support the ankle. Small-diameter air bladders can press painfully on shins. Primary consequences: - inadequate stabilization of the ankle (the boot's primary job). Compliance is compromised due to the pain of the bladders pressing into shine. Compliance is compromised because the boot doesn't help to stabilize the leg why should i wear it if it doesn't help? Poor design: the inflated air bladders are minuscule, about the size of a broomstick, 1-1/2" diameter, and 8" high. When pressing the "deflate" button for the air bladders, only a small amount of air is released. Because of this poor deflation, when putting on the boot again, the inflated broomstick-size bladders press painfully on the sides of the shin. Difficult to locate the cause of this pain. The bladders are not visible, as they are under the lining of the boot, not integrated into the padded boot insert like other walker boots. Medical consequences: stabilization of the ankle is compromised and that is its main job. Compliance is compromised due to the painful bladders pressing into your shin. Compliance is compromised because the boot doesn't seem to be doing any good, your ankle wobbles around in the boot. It's a pain in the neck to wear the thing anyway, so i'm not going to be motivated to wear it if it's not supporting my ankle. I borrowed another boot from a friend, and discovered a vastly different design. The bladders wrap around my entire ankle and shin, as well as cushioning the sides of my foot.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5057315
MDR Report Key5179882
Date Received2015-10-19
Date of Report2015-10-19
Date of Event2015-10-16
Date Added to Maude2015-10-27
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 NameGENESIS FULL SHELL WALKER BOOT
Generic NameWALKER BOOT
Product CodeKNP
Date Received2015-10-19
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDICAL TECHNOLOGY, DBA BLEDSOEBRACE


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-10-19

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