inforMED
InjuryIPG

MAXTRAX WALKER (BOOT) (DJO, LLC)

Received Nov 19, 2007 · Event occurred Sep 19, 2007

Report MW5004489 · MDR key 951200

Device

Generic name

"fracture Boot" " Walker Boot"

Manufacturer

Djo, Llc

Lot number

090507

Product problems

  • Unknown (for use when the device problem is not known)

Patient

YR

  • Blister(s)
  • Erythema
  • Hematoma
  • Unspecified Infection
  • Pain
  • Swelling
  • Injury
  • Impaired Healing
  • Skin Tears

Narrative

Description of Event or Problem

HAD INJURY TO FOOT, ANKLE & LEG (RIGHT) IN 2007. TAKEN TO EMERGENCY. DIAGNOSIS-FRACTURES, "CRUSHED FOOT", SPRAINED ANKLE, PLUS 2 LESIONS AND A FRACTURE BLISTER) HAD LARGE HARDENED HEMATOMA (APPROX 3"X3") DARK RED, SWOLLEN-LEFT SIDE NEAR ANKLE. STITCHES WERE PUT ON OTHER WOUND ON RIGHT SIDE. FOLLOWED INSTRUCTIONS FOR CLEANING/CHANGING DRESSINGS ON 3 LESIONS FOR 5 DAYS UNTIL DR APPT (DR), SIX DAYS LATER. LEFT SIDE (OF RIGHT FOOT) WOUND WAS HEALING - SOFTENED BLISTER FORMED ON LEFT TOP EDGE - JUST BEFORE DR APPT (HAVE PHOTOS) AFTER NURSE IN DR OFFICE CHANGED BANDAGES ON WOUND (WHILE WAS ON PAIN MEDICATION), MAN CAME IN TALKING QUICKLY, WITH THIS "FRACTURE FOOT" PUSHED ME TO PUT BOOT ON EVEN AFTER, I SAID IT WAS TOO PAINFUL TO FIT MY SWOLLEN FOOT/ANKLE IN IT. DR WAS NOT AROUND. I WAS IN WHEELCHAIR, IN SHOCK, I TRIED TO BEAR IT, BUT AFTER I GOT HOME, IT BECAME EXCRUCIATING PAIN & I FOUND BOOT BURST "HEMATOMA" PREMATURELY-RIPPED SKIN OFF-CAUSING OPEN WOUND, REDDENED SKIN. ELSEWHERE, FURTHER INJURY PAIN AND FEAR OF DR AND INFECTION. WOUND HAS NOT HEALED AFTER ONE MONTH.(STITCHED WOUND IS STILL RED ON OTHER SIDE) I TOOK "BOOT" OFF AFTER A FEW HOURS, ON THE SAME DAY, WHEN PAIN WAS UNBEARABLE. WHEN BANDAGE WAS REMOVED THE NEXT DAY. I SAW DAMAGES FROM BOOT). [WE HAVE PHOTOS FROM VARIOUS STAGES BEFORE. AFTER BOOT DAMAGE AND REMOVAL]. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: FRACTURES/CONTUSIONS/SOFT TISSUE DAMAGE OF LESIONS, SPRAINED ANKLE, HEMATOMA INTERNAL INJURIES. EVENT ABATED AFTER USE STOPPED: NO.