SENSURA MIO CONCAVE CLICK OSTOMY BASEPLATE

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, THE COMPLAINT DESCRIBED IN (B)(4) CONCERNS AN END-USER WHO REPORTED THAT HIS STOMA SIZE INCREASED TO 57MM AND THAT THE COUPLING SYSTEM WOUNDED HIM OVER TIME AND MADE HIM HEMORRHAGE WHEREFORE HE LOST 1.5 LITERS OF BLOOD. HE HAD TO BE TAKEN URGENTLY TO THE HOSPITAL. HE HAS RECOVERED BUT HAS ANEMIA AFTER THE INCIDENT, WHICH HE HAS TO TREAT. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 14TH STATING THAT THE END-USER RECOGNIZED THAT IT WAS NOT THE FAULT OF COLOPLAST, BUT HE WAS NOT CUTTING THE BASEPLATE TO THE RIGHT SIZE OF HIS STOMA. THE END-USER ACKNOWLEDGES THAT THE STOMA HAS INCREASED IN SIZE AND THAT THE COUPLING SYSTEM HAS WOUNDED HIM OVER TIME. HE LET HIMSELF BLEED FOR THREE DAYS BEFORE AN AMBULANCE WAS CALLED. HE WAS KEPT IN THE HOSPITAL FOR TWO DAYS AND IS NOW OK (EXCEPT SAID ANEMIA). HE HAS NOT VOLUNTEERED ANY INFORMATION CONCERNING THE INTERVENTION THAT WAS DONE AT THE HOSPITAL, NOR HIS MEDICAL HISTORY. ALSO, IT IS NOT KNOWN HOW THE AMOUNT OF BLOOD LOST WAS ASSESSED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

NO SAMPLES WERE RECEIVED FOR INVESTIGATION. BASED ON THE AVAILABLE INFORMATION CONTAINED IN THE COMPLAINT, IT WAS ASSESSED THAT THE BLEEDING HAD RISEN DUE TO MISUSE OF THE PRODUCT. THE BLEEDING WAS ASSESSED AS PROBABLY/MOST LIKELY LINKED TO THE DEVICE BASED ON THE AVAILABLE INFORMATION.