inforMED
InjuryITJ

CAREX

Received Sep 10, 2020 · Event occurred Aug 5, 2020

Report 3012316249-2020-00028 · MDR key 10514808

Device

Generic name

Rollator

Model number

FGA22200 0000

Catalog number

A222-00

Product problems

  • Defective Component
  • Defective Component

Patient

82 YR

  • Laceration(s)
  • Limb Fracture
  • Laceration(s)
  • Limb Fracture

Narrative

Description of Event or Problem

HAS HAD SINCE 2012. THE LEFT BRAKE WAS HOLDING. WAS IN THE NURSING HOME AND SHE THOUGHT THAT THE BRAKES WERE ADJUSTED DURING THE 5 1/2 YEARS THAT SHE WAS IN THERE. 2 WEEKS AGO SHE WENT TO SIT ON IT AND IT SCOOTED AWAY FROM HER CAUSING HER TO FALL. WHEN SHE FELL SHE HIT HER RIGHT ARM ON AN OPEN PART THAT COVERS THE SPRING OF THE BRAKE ON THE RIGHT SIDE. IT CUT HER ARM FROM HER ELBOW DOWN TO HER WRIST. SHE ALSO HIT HER RIGHT HAND ON THE FREEZER HANDLE AND BROKE HER RIGHT HAND. SHE SAW A DOCTOR SEVERAL TIMES. SHE FEELS THAT THE ROLLATOR IS IN PERFECT SHAPE EVEN THOUGH IT IS 12 YEARS OLD. SHE DOESN'T KNOW THE LAST TIME THAT THE BRAKES WERE ADJUSTED. THEY DID STERI-STRIPS AND THEN BANDAGES BECAUSE OF HER AGE. THEY PUT A SPLINT ON HER HAND. SHE BROKE THE METATARSAL BONE THAT GOES TO THE LITTLE FINGER. AS FAR AS SHE KNOWS THE BRAKES WERE LOCKED BEFORE SHE SAT ON IT. SHE ALWAYS LOCKED THE BRAKES BEFORE SHE SITS ON IT.