MODERMAFLEX OSTOMY APPLIANCE

Additional Manufacturer Narrative

TREND ANALYSIS WAS CONDUCTED, AND NO ADVERSE TRENDS WERE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) CONFIRMED THAT MANUFACTURING DOCUMENTATION WAS COMPLETE AND MET APPLICABLE SPECIFICATIONS. THE DEVICE SAMPLE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. AS A RESULT, THE ROOT CAUSE OF THE REPORTED CONTACT DERMATITIS COULD NOT BE DETERMINED. THE DEVICE MATERIALS HAVE BEEN EVALUATED FOR BIOCOMPATIBILITY IN ACCORDANCE WITH APPLICABLE STANDARDS, AND THE RESULTS SUPPORT THAT THE DEVICE MEETS ESTABLISHED ACCEPTANCE CRITERIA FOR ITS INTENDED USE AND DURATION OF CONTACT. HOWEVER, INDIVIDUAL PATIENT SENSITIVITY TO DEVICE COMPONENTS CANNOT BE RULED OUT. THIS SPECIFIC PRODUCT CONFIGURATION IS NOT MARKETED IN THE UNITED STATES; HOWEVER, A SIMILAR PRODUCT (SKU 89511) IS COMMERCIALLY AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD BEEN EXPERIENCING PERISTOMAL SKIN ISSUES. IT WAS REPORTED THAT THE PERISTOMAL SKIN WAS HEALTHY AND INTACT BUT BELOW THAT, WHERE THE POUCH HANGS DOWN, THE PATIENT HAD DEVELOPED SOME CONTACT DERMATITIS. ADDITIONALLY, IT WAS REPORTED THAT A DERMATOLOGIST PRESCRIBED SOME STEROID CREAM, WHICH CLEARED UP THE DERMATITIS, BUT WITHIN 4 DAYS OF STOPPING THE CREAM IT HAD RECURRED.