ADAPT PASTE

Description of Event or Problem

IT WAS REPORTED THAT OVER A PERIOD OF 3-4 MONTHS, THE USER NOTED SKIN INFECTION AND SEROUS LEAKAGE UNDER THE OSTOMY BARRIER IN THE AREA WHERE ADAPT SKIN BARRIER PASTE WAS USED. HE WENT TO THE DOCTOR AND WAS PRESCRIBED ORAL ANTIBIOTICS. THE AREA STARTED TO CLEAR UP BUT THEN BECAME WORSE. ON (B)(6) 2013, HE WAS HOSPITALIZED AND IV MEDICATION WAS ADMINISTERED. THE MEDICATION RECEIVED IS UNKNOWN BUT THE DRAINAGE WAS CLEARING UP WHILE HE WAS IN THE HOSPITAL AND NOT USING ADAPT PAST. HE WAS DISCHARGED FROM THE HOSPITAL AND BEGAN TO USE ADAPT PASTE AGAIN WITH A NOTED INCREASE IN DRAINAGE AROUND THE STOMA. HE WENT BACK TO THE HOSPITAL WHERE THEY TREATED HIM AGAIN AND INSTRUCTED HIM TO STOP USING THE ADAPT PASTE. NO ALLERGY TESTING WAS PERFORMED AND IT IS UNKNOWN WHAT TYPE OF INFECTION OR REACTION HE WAS HAVING.

Additional Manufacturer Narrative

WITHOUT THE SAMPLE, THE REPORTED INCIDENT IS UNABLE TO BE FULLY EVALUATED. THE IFU STATES "DO NOT APPLY TO SEVERELY IRRITATED OR ERODED SKIN, OPEN CUTS OR SORES." THE PATIENT CONTINUED TO USE THE PRODUCT UNTIL THE HOSPITAL TOLD HIM NOT TO AT HIS LAST VISIT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REVIEWED AND A FOLLOW UP REPORT SUBMITTED AS NEEDED. HOLLISTER WILL CONTINUE TO MONITOR THE PRODUCT'S PERFORMANCE FOR ANY TRENDS.