inforMED

HUGO

Received Sep 15, 2016 · Event occurred Sep 11, 2016

Report 8022077-2016-00066 · MDR key 5952578

Device

Generic name

Hugo Elite Rolling Walker With A Seat

Manufacturer

Amg Medical Inc.

Model number

700-959

Product problems

  • Break

Patient

82 YR

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

Narrative

Additional Manufacturer Narrative

WE SENT THE END-USER A REPLACEMENT ROLLING WALKER TO HIS HOME. THIS IS A (B)(6) ROLLATOR AND WE DO NOT KNOW IF IT WAS EVER USED AS A TRANSPORT CHAIR. WE HAVE DONE ALL SORTS OF CORRECTIVE ACTIONS ON THIS PARTICULAR UNIT OVER THE YEARS AND HAVE CLEAR VISIBLE WARNING LABELS ON THE UNIT STATING THAT IT SHOULD NOT USED AS A TRANSPORT CHAIR. EVEN WITH THE VISIBLE WARNINGS, CUSTOMERS STILL USE THE ROLLING WALKER AS A TRANSPORT CHAIR. THIS COULD CONTRIBUTE TO THE BREAKAGE OF THE UNIT. THE CLAIM IS NOW CLOSED.

Description of Event or Problem

THE METAL TUBING BROKE OFF CAUSING THE END-USER TO FALL ONTO THE FLOOR. HE BRUISED HIMSELF.