PM-19858
Ureteral Dilators Brief Statement
Intended Use
Ureteral dilators are intended to be used for dilation of the ureteral meatus and distal ureter.
Intended Medical Indication
The ureteral dilators are used retrogradely to dilate the ureteral meatus and the distal ureter. Ureteral dilation may be required when starting an endoscopic procedure.
Contraindications
Contraindications to the medical device: None known
Contraindications to the procedure including, but not limited to:
- Untreated urinary tract infections.
- Uncorrected haemostasis disorders (relative contraindication)
- Do not use, when in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
Warnings and Precautions
This device must only be used by trained and experienced physicians. Evaluation of a patient’s potential allergic reaction to the device is the healthcare professional’s responsibility.
Potential Complications
The following events have been reported with ureteral dilators although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: infection (e.g., urinary tract infection, pyelonephritis, severe infection), bleeding (e.g., hematuria), urinary tract injuries (e.g., tissue trauma, ureteral perforation…).
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-19627 / Jul 2025
