inforMED
InjuryQKA

ITIND, WITH SNARE, STERILE

Received Oct 31, 2025 · Event occurred Sep 29, 2025

Report 2429304-2025-00285 · MDR key 23437818

Device

Generic name

Wa2ita00

Manufacturer

Medi-tate Ltd.

Model number

WA2ITA00

Lot number

U1S04122023-1

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Male

  • Micturition Urgency
  • Implant Pain
  • Micturition Urgency
  • Implant Pain

Narrative

Description of Event or Problem

AT THE POST-IMPLANT VISIT, THE PATIENT STATED PAIN DISRUPTED HIS DAILY ACTIVITIES, AFFECTING HIS ATTENDANCE AT WORK DUE TO DISCOMFORT. HE HAD TO LEAVE WORK EARLY DUE TO INTENSE PAIN AND PRESSURE AND A CONSTANT NEED TO URINATE. THE PATIENT RATED THE PAIN TEN OUT OF TEN. THE PAIN RESOLVED AFTER THE DEVICE REMOVAL VISIT. THERE WERE NO FURTHER REPORTS OF PATIENT IMPACT.