ACCESSORIES

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

Description of Event or Problem

IN (B)(6) 2020, THE END USER TRIED A DIFFERENT CONVATEC PRODUCT AND THE LOW PRESSURE ADAPTER FAILED (WAS NOT WORKING RIGHT). IT LEFT THE URINE GATHERING ALONG THE STOMA AS IT DID NOT ALLOW THE RELEASE OF URINE INTO THE BAG (NOT OPENING PROPERLY), WHICH CAUSED THE WAFER TO BREAK DOWN AND LEAK. AT THIS POINT, HE PASSED OUT AND HAD HIS DOG THERE TO HELP WAKE HIM. HE WOKE UP DIZZY AND DID NOT FEEL WELL AFTER RETURNING HOME VIA PLANE FROM SEATTLE. THEREAFTER, HE WENT TO HIS DOCTOR AND PASSED OUT. HE WAS DIAGNOSED WITH URINARY TRACT INFECTION. HIS DOCTOR CALLED AN AMBULANCE TO TAKE HIM TO THE HOSPITAL. HE STATED THAT "THE DOCTOR SAID I DIED ON THE TABLE TWICE, AND THE DOCTORS BROUGHT HIM BACK". REPORTEDLY, HE WAS IN THE INTENSIVE CARE UNIT FOR A COUPLE DAYS. SEPSIS WAS RULED OUT. HE WAS IN THE HOSPITAL FOR 2 WEEKS. THE END USER DID NOT REMEMBER A LOT OF WHAT HAPPENED AS HE WAS "OUT OF IT". HE STATED THE DOCTOR TOLD HIM THE INFECTION WAS DUE TO THE WAFER BREAKING DOWN. HE RECEIVED ANTIBIOTICS VIA INTRAVENOUS ROUTE AND A COMPUTERIZED AXIAL TOMOGRAPHY SCAN. HE WAS "REVIVED 4-5" TIMES. WHEN HE WAS DISCHARGED FROM THE HOSPITAL, HE WAS ON 800MG OF AN ANTIBIOTIC RECEIVED INTRAVENOUSLY THROUGH A PORT IN HIS ARM FOR 6 WEEKS. THE PATIENT IS A CANCER SURVIVOR AND THE MEDICATION THEY SENT HIM HOME ON VIA PORT WAS WORSE THAN CHEMO. NO PHOTO IS AVAILABLE AT THIS TIME.