PureWick™ Female External Catheter

Intended Users

• User/Patient
• Caregiver/Healthcare Professional

Contraindications:

• Patients with urinary retention

Warnings:

• Never insert the PureWick™ Female External Catheter into vagina, anal canal, or other body cavities. FOR EXTERNAL USE ONLY
• Do not use the PureWick™ Female External Catheter with bedpan or any material that does not allow for sufficient airflow
• To avoid potential skin injury, never push or pull the PureWick™ Female External Catheter against the skin during placement or removal
• Discontinue use if an allergic reaction occurs
• Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device which may lead to device failure, and/or lead to injury or illness of the patient
• After use, this product may be a potential biohazard. Dispose of in accordance with applicable local, state and federal laws and regulations

Precautions:

• Not recommended for patients who are:
  • Agitated, combative, or uncooperative and might remove the PureWick™ Female External Catheter 
  • Having frequent episodes of bowel incontinence without a fecal management system in place
  • Experiencing skin irritation or compromise at the site
  • Experiencing moderate/heavy menstruation and cannot use a tampon
• When using the PureWick™ Female External Catheter, do not use barrier cream on the perineum, as this may impede suction
• Proceed with caution in patients who have undergone recent surgery of the external urogenital tract
• Always assess skin for compromise and perform perineal care prior to placement of a new PureWick™ Female External Catheter 
• Maintain suction until the PureWick™ Female External Catheter is fully removed from the patient to avoid urine backflow

Recommendations:

• Perform each step with clean technique. In the home setting, wash hands thoroughly before device placement
• Prior to connecting the PureWick™ Female External Catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial. If the pressure does not increase when the line is covered, verify that the tubing is secured, connected, and not kinked
• Ensure the PureWick™ Female External Catheter remains in the correct position after turning the patient. Remove the PureWick™ Female External Catheter prior to ambulation
• Properly placing the PureWick™ Female External Catheter snugly between the labia and gluteus holds the PureWick™ Female External Catheter in place for most patients. Mesh underwear may be useful for securing the PureWick™ Female External Catheter for some patients
• Assess device placement and patient's skin at least every 2 hours
• Replace the PureWick™ Female External Catheter every 8-12 hours or if soiled with faeces or blood
• If using wall suction, change suction tubing per hospital protocol or at least every 30 days
• If using PureWick™ Urine Collection System, replace accessories per PureWick™ Urine Collection System user guide

If experiencing problems with the use of the device, please consult your healthcare professional for assistance.

Any serious incident that occurs with use of the device should be reported to the manufacturer and the Member State's Competent Authority in which the user and/or patient is established.