inforMED
MalfunctionITJ

STEEL ROLLATOR WITH 6" WHEELS, KNOCKDOWN

Received Dec 23, 2025 · Event occurred Nov 11, 2025

Report MW5181044 · MDR key 23878104

Device

Generic name

Walker, Mechanical

Product problems

  • Material Deformation
  • Therapeutic or Diagnostic Output Failure

Patient

74 YR · Female

  • Fall
  • Discomfort
  • Fall
  • Discomfort

Narrative

Description of Event or Problem

THE PATIENT REPORTED THAT THE WHEELS ON THE DRIVE R800 ROLLATOR WALKER MALFUNCTIONED AND WERE REPLACED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED THAT THE WALKER FRAME BOWED OUTWARD AND FAILED WHEN SHE ATTEMPTED TO SIT ON THE SEAT. THE PATIENT FELL TO THE GROUND AS A RESULT OF THE REPORTED FRAME FAILURE. THE ORGANIZATION CONTACTED THE PATIENT ON (B)(6) 2025 TO ASSESS FOR INJURY. THE PATIENT REPORTED MILD SORENESS BUT DID NOT SEEK OR PLAN TO SEEK MEDICAL EVALUATION. NO INJURY REQUIRING TREATMENT WAS REPORTED. A REPLACEMENT WALKER WAS PROVIDED TO ENSURE SAFE AMBULATION WHILE THE EVENT WAS BEING EVALUATED.