inforMED
MalfunctionFEN

URODYNAMIC URINARY CATHETER

Received Jan 20, 2021 · Event occurred Jan 12, 2021

Report MW5098931 · MDR key 11207568

Device

Generic name

Device, Cystometric, Hydraulic

Model number

CAT895

Lot number

192516

Product problems

  • Increase in Pressure
  • High Readings

Patient

11 YR

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

URODYNAMIC CATHETER MALFUNCTIONED LEADING TO READING HIGH PRESSURES. FDA SAFETY REPORT ID # (B)(4).