PM-19762
Folysil Catheters Brief Statement
Indications
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for:
- Bladder drainage by urethral catheterization,
- Bladder drainage by suprapubic catheterization for catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).
- Bladder instillation of physiological saline solution.
Contraindications to the medical device:
- Allergy to any component of the device.
- Do not use, if such a procedure would be contrary to the best interest of the patient, in the judgement of the physician.
Contraindications to urethral urinary catheterization
Including but not limited to:
- Urethral trauma, urethral injury, urethritis
- Complete urethral obstruction or urethral stenosis refractory to urethral insertion of the catheter
- Acute prostatitis
- Priapism
- Presence of urethral or prostatic prosthesis
Contraindications to suprapubic bladder drainage
Including but not limited to:
- Known or suspected bladder cancer
- Altered anatomy or anticipated significant adhesions (e.g. pelvic cancer, radiation, suprapubic mesh)
- Ascites, gross or morbid obesity
- Hematuria
- Uncontrolled hemostasis disorder
Warnings & Precautions
This type of device must only be used by trained and experienced professionals.
Potential Complications
The following events have been reported with Folysil catheters, although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: Vesical discomfort, pain, mucosal irritation, mucosal erosion, uro-genital trauma, urethritis, cystitis, urinary tract infection, pyelonephritis, encrustation, stone formation, urinary retention, urine leakage, bleeding, bladder spasms, urethral perforation, urethral stricture and fistula, misplacement, false passage, displacement, reintervention, skin irritation and skin infection specially for suprapubic catheterization.
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-34784, October 2024
