SENSURA MIO HIGH OUTPUT FLEX OSTOMY BAG 2-PIECE

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, IN TWO SEPARATE INSTANCES WITH PRODUCTS FROM THE SAME BOX OF SENSURA MIO HIGH OUTPUT FLEX OSTOMY BAG 2-PIECE, BOTH THE CONSUMER AND HER NURSE NOTICED MOLD GROWTH ON THE SKIN. THE LOCATION ON THE SKIN WHERE THE MOLD WAS NOTICED IS NOT DESCRIBED, SO IT IS NOT KNOWN WHETHER THE MOLD WAS SEEN IN THE IMMEDIATE PERISTOMAL AREA OR FURTHER AWAY FROM THE STOMA. ON THE MOST RECENT OCCASION, THE POUCH WAS ON FOR 3 DAYS. WHEN THE CONSUMER REMOVED THE POUCH, BOTH SHE AND THE NURSE NOTICED THE MOLD. ONE WEEK LATER, THE CONSUMER WAS SENT TO THE ER WITH FATIGUE AND A FEVER OF 104ºF (40ºC). SHE WAS ADMITTED INTO THE HOSPITAL, HAD CULTURES TAKEN, AND THE DOCTORS UNCOVERED SHE WAS IN SEPTIC SHOCK. THE CONSUMER STAYED IN THE HOSPITAL FOR 3 WEEKS UNTIL SHE WAS DISCHARGED. WHEN SHE WAS AT HOME, SHE STAYED ON ANTIBIOTICS FOR A SHORT WHILE. AS OF TODAY - THE CONSUMER HAS FULLY RECOVERED FROM THE SEPTIC SHOCK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.