FDA Adverse Event Malfunction Summary report: N

GENESIS FULL SHELL WALKER BOOT

MDR report key: 5179882 · Received October 19, 2015

Report

Report Number
MW5057315
Event Type
Malfunction
Date Received
October 19, 2015
Date of Event
October 16, 2015
Report Date
October 19, 2015
Manufacturer
MEDICAL TECHNOLOGY, DBA BLEDSOEBRACE
Product Code
KNP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
689947 GENESIS FULL SHELL WALKER BOOT WALKER BOOT KNP MEDICAL TECHNOLOGY, DBA BLEDSOEBRACE

Patients

Seq Age Sex Outcome Treatment
1 55 YR Other