Contraindications - ConvaTec Flexi Seal Protect Plus Gebrauchsanweisung

Contraindications

1. This product is not intended for use
• for more than 29 consecutive days
• for pediatric patients as its use has not been tested in this population
2. The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ Connector) should not be used on
individuals who
• have suspected or confirmed rectal mucosal impairment, i.e. severe proctitis, ischemic proctitis, mucosal
ulcerations
• have had rectal surgery within the last year
• have any rectal or anal injury
• have hemorrhoids of significant size and/or symptoms
• have a rectal or anal stricture or stenosis
• have a suspected or confirmed rectal/anal tumor
• have any in-dwelling rectal or anal device (e.g. thermometer) or delivery mechanism (e.g. suppositories or
enemas) in place
• are sensitive to or who have had an allergic reaction to any component within the system
Warnings
• Warning: Clinicians should be aware that there are very limited clinical data on the use of in-dwelling fecal
management systems after 14 days continued use.
• Warning: There is a potential risk of misconnections with connectors from other healthcare applications, such as
intravenous equipment, breathing and driving gas systems, urethral/urinary, limb cuff inflation neuraxial devices
and other enteral and gastric applications.
• Warning: Not following these instructions for use may increase the likelihood of an adverse event.
• Warning: Patients should be monitored daily and a physician notified immediately if any of the following occur
- Rectal pain
- Rectal bleeding
- Abdominal symptoms such as distension/pain
• Warning: Over inflation of the retention balloon has the potential to increase the risk of adverse events including
rectal pain, bleeding, ulcerations, and possible perforations.
• Warning: There is a danger of fecal obstructions with this product.
• Warning: The output may appear darker than usual and/or may contain black flecks. This is a visible indication
of the ConvaTec Diamonds™. If monitoring output color, please use the sampling port or catheter. In case of
contact with eyes, rinse immediately with clean water and seek medical advice. Store the ConvaTec Diamonds™
in a cool dry place. Do not open sachet. Keep out of the reach of children.
Precautions and observations
1. Close attention should be exercised with the use of the device in patients who have inflammatory bowel
conditions or who have had rectal surgery. The physician should determine the degree and location of
inflammation or extent of surgery (e.g. location of anastomosis) within the colon/rectum prior to considering use
of this device in patients with such conditions.
2. Care should be exercised in using this device in patients who tend to bleed from either anti-coagulant /
antiplatelet therapy or underlying disease. If signs of rectal bleeding occur, remove the device immediately and
notify a physician.
3. The device should be used with caution in patients with spinal cord injury because of the possibility of the
development of autonomic dysreflexia.
4. Remove any indwelling or anal device prior to insertion of the Flexi-Seal™ PROTECT PLUS (with ENFit™
Connector) and do not insert any other devices into the rectum while the Flexi-Seal™ PROTECT PLUS (with
ENFit™ Connector) is in place.
5. Ensure that the patient does not lie or sit on the catheter as this could lead to localized pressure damage and
contribute to the development of anal skin breakdown and/or restrict fecal flow.
6. Solid or soft-formed stool cannot pass through the catheter and will obstruct the opening. The use of the device
is not indicated for solid or soft-formed stool.
7. Small amounts of moisture or seepage around the catheter is anticipated. To avoid skin irritation, initiate an
appropriate institutional skin care protocol. At a minimum, the skin should be kept clean, dry and protected with
a moisture barrier product.
4 | Flexi-Seal™ PROTECT PLUS Fecal Management System