SUR-FIT NATURA

Description of Event or Problem

THE END USER REPORTED THAT, OVER THE PREVIOUS SIX MONTHS, THE PRODUCT MASS HAD BECOME STIFFER, LESS FLEXIBLE, AND LESS ADHESIVE FOLLOWING THE INTRODUCTION OF NEW PACKAGING. AS A RESULT, THE WEAR TIME DECREASED FROM THE USUAL THREE TO FOUR DAYS TO APPROXIMATELY TWELVE HOURS, AND EPISODES OF LEAKAGE WERE EXPERIENCED. THE ASSOCIATED LOT NUMBER WAS UNKNOWN. THE END USER FURTHER REPORTED THAT HIS STOMA DEVELOPED A LACERATION ACCOMPANIED BY BLEEDING, WHICH HE ATTRIBUTED TO THE REDUCED FLEXIBILITY OF THE PRODUCT MASS. HE SOUGHT MEDICAL CARE ON TWO OCCASIONS; HOWEVER, NO MEDICAL INTERVENTION WAS PROVIDED DURING EITHER VISIT, AND HE WAS ADVISED TO TAKE IT EASY. THE END USER WAS UNABLE TO QUANTIFY THE AMOUNT OF BLOOD LOSS AND STATED THAT HIS HEALTHCARE PROVIDER CONSIDERED THE INJURY TO BE SUPERFICIAL. THE END USER CONTINUED USING THE PRODUCT THROUGHOUT THE EVENT PERIOD. HE DENIED ANY CHANGES IN HIS ROUTINE OR THE PRODUCTS USED AND CONFIRMED CONSISTENT USE OF OTHER COMPANY'S ADHESIVE REMOVERS, SOAP, AND SKIN TAC ADHESIVE. HE ALSO STATED THAT REPLACEMENT PRODUCTS SUPPLIED IN THE PREVIOUS PACKAGING RESOLVED THE ISSUE; HOWEVER, THE PROBLEM RECURRED WHEN HE RESUMED USE OF THE NEWLY PACKAGED PRODUCT. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT HAD A COLOSTOMY AND REPORTED A STOMA SIZE OF TWENTY-FIVE MILLIMETER (MM). HE STATED THAT A TWENTY-TWO MILLIMETER (MM) PRODUCT OPENING FIT APPROPRIATELY WITHOUT THE NEED FOR MOLDING AND WITHOUT COVERING THE STOMA, ALTHOUGH HE WAS ADVISED TO REMEASURE THE STOMA SIZE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION.REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS.TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.FDA REGISTRATION NUMBER:REPORTING SITE: 1049092, MANUFACTURING SITE: 9618003.