inforMED
InjuryIPS

CAREX

Received Sep 15, 2017

Report 3012316249-2017-00117 · MDR key 6869056

Device

Generic name

Offset Adjustable Designer Cane

Model number

FGA51700 BRNZ

Catalog number

A517-00

Product problems

  • Bent

Patient

54 YR

  • Bruise/Contusion
  • Fall
  • Bruise/Contusion
  • Fall

Narrative

Description of Event or Problem

THE USER STATES THAT HE HAS TWO CANES THAT HE HAD PURCHASED ABOUT SIX MONTHS AGO. HE USES BOTH OF THE CANES SIMULTANEOUSLY, ONE FOR EACH HAND. HE STATES THAT HE WAS USING THE CANES, AND THE SHAFT OF ONE OF THEM BENT, AND HE FELL. HE STATES THAT HE WAS HOSPITALIZED FOR A MONTH WITH FRACTURED RIBS, BRUISED KIDNEYS, AND ALSO HAD A HEART ATTACK BECAUSE OF THE STRESS OF FALLING. HE DID ALSO MENTION THAT THE CANE "GIVES A LITTLE." THE EVENT IS REPORTED AS HAVING OCCURRED ON A LINOLEUM SURFACE IN A BATHROOM. THE RUBBER FEET OF THE CANE ARE REPORTED AS HAVING BEEN FREE OF SPLITS, CRACKS, OR TEARS, AND ITS LOCK KNOB IS REPORTED AS HAVING BEEN PROPERLY TIGHTENED, THE SNAP BUTTON ALSO FUNCTIONING PROPERLY.

Description of Event or Problem

THE DEVICE INVOLVED WITH THIS EVENT WAS RETURNED TO COMPASS HEALTH BRANDS AND EVALUATED ON 11/14/2017. THE CUSTOMER'S COMPLAINT COULD BE CONFIRMED FROM A REVIEW OF THE RETURNED DEVICE. THE RETURNED CANE WAS FOUND TO HAVE THE LOWER SECTION OF ITS FRAME/TUBING BENT IN A FORWARD "10 O'CLOCK POSITION" - THE FRAME/TUBING APPEARS TO LOOK LIKE IT IS CRIMPED AS A RESULT OF THE BEND. THIS BEND HAPPENED 9 INCHES ABOVE THE BASE OF THE CANE - THE MEASURED DIAMETER OF THE LOWEST SECTION OF THE TUBING WAS 19.09MM. THE BEND WAS MEASURED AS WIDTH & WIDTH (VERTICALLY & HORIZONTALLY), BECAUSE IT IS NO LONGER A CIRCLE - THE BEND MEASURED AT 10.55MM & 24.78MM; THE LARGEST MEASUREMENT IS DUE TO THE TUBING FLATTENING OUT. THE HANDLE GRIP WAS ALSO FOUND TO HAVE ELECTRICAL TAPE WRAPPED AROUND IT. AGAIN, THE CUSTOMER'S COMPLAINT COULD BE CONFIRMED FROM A REVIEW OF THE RETURNED DEVICE.