inforMED
InjuryFAD

UNKNOWN URETERAL STENTS

Received Apr 4, 2026 · Event occurred Mar 30, 2026

Report 1018233-2026-02231 · MDR key 24784468

Device

Generic name

Ureteral Stent

Catalog number

UNK

Lot number

UNK

Product problems

  • Patient Device Interaction Problem

Patient

NA · Unknown

  • Pain
  • Unspecified Kidney or Urinary Problem
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

CRITICAL CARE PHYSICIAN REPORTED IN THE ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS URINARY SYMPTOMS ASSOCIATED WITH THE DEVICE INLAY OPTIMA¿ URETERAL STENT WITHOUT GUIDEWIRE. THAT RESULTED IN STENT REMOVAL.

Additional Manufacturer Narrative

INITIAL REPORTER PHONE NUMBER: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.