SENSURA MIO CLICK UROSTOMY POUCH

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN ADDED TO THE "REPORT INCIDENT DESCRIPTION" CONCLUDING IN ANNEX F BEING UPDATED WITH AN ADDITIONAL CODE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON THE (B)(6) 2021 THE PATIENT CONFIRMED THAT THE BLOCKAGE AND THE PRESENCE OF THE BACTERIA IN THE BLADDER LED TO THE SEPSIS. AS THE CONSEQUENCE OF THE INCIDENT, THE PATIENT WAS HOSPITALIZED FOR 7 DAYS AND AND REQUIRED TREATMENT WITH VANCOMYCIN BY INTRAVENOUS DRIP AN THEN ORAL ANTIBIOTIC.

Additional Manufacturer Narrative

WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED TO COLOPLAST THAT THERE WAS AN INCIDENT WITH THE INVOLVEMENT OF SENSURA MIO CLICK UROSTOMY BAG. FOLLOWING THE INFORMATION COLLECTED, THE BAG BECAME TWISTED, CAUSING THE URINE NOT TO FLOW PROPERLY INTO THE BAG. THE END USER SUSTAINED URINARY REFLUX THAT LED TO A SEPTIC SHOCK. THE RELATIONSHIP BETWEEN THE PATIENT'S SEPSIS AND THE REPORTED BAG MALFUNCTION YET REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.