Description of Event or Problem · 0
IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2024 THAT THE BIOPROTECT BALLOON IMPLANT SYSTEM WAS IMPLANTED DURING PROCEDURE PERFORMED ON (B)(6) 2024. REPORTEDLY, THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. AFTER PROCEDURE COMPLETION AND DURING THE FINAL DIGITAL RECTAL EXAM (DRE), A RECTAL PERFORATION WAS IDENTIFIED, AND THE BALLOON WAS REMOVED TRANSRECTALLY WITH MINIMAL BLOOD LOSS OF ABOUT 30 CC PR. THE PATIENT WAS DIAGNOSED WITH LINEAR LACERATION IN THE ANTERIOR ANORECTAL MUCOSA. THE PATIENT WAS ADMITTED FOR OBSERVATION AND IV ANTIBIOTICS AS A PRECAUTIONARY MEASURE, WITH A LIQUID DIET. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 AND REPORTED WITH NO SIGNS OF INFECTION, ACUTE ABDOMEN, FEVERS OR CHILLS, AND WITH ORAL FLAGYL WITH VERY GOOD PROGNOSIS FOR COMPLETE HEALING. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP IN A FEW WEEKS FOR A POSSIBLE ANO-SCOPIC EXAMINATION.