ORISE GEL

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DATE OF EVENT: THE EXACT DATE OF THE EVENT IS UNKNOWN. IT WAS REPORTED THAT THE ESD PROCEDURE WAS PERFORMED IN APRIL 2022. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED IN (B)(6) 2021. IN (B)(6) 2022, A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS PERFORMED TO EVALUATE A LUNG NODULE FOR A SEPARATE ISSUE. THE PET SCAN SHOWED A "HOT SPOT" IN THE DUODENUM AT THE SAME LOCATION AS THE ESD PERFORMED IN (B)(6) 2021. IT WAS STATED THAT THE PHYSICIAN ATTRIBUTED THIS FINDING TO ORISE INFLAMMATION. AS A RESULT OF THE FINDINGS ON THE PET SCAN, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH BIOPSY IN (B)(6) 2022. THE BIOPSY SHOWED "PEPTIC DUODENITIS WITH ULCERATION".

Additional Manufacturer Narrative

BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. IT WAS REPORTED THAT THE ESD PROCEDURE WAS PERFORMED IN (B)(6) 2022. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE. BLOCK H11: BLOCKS D4, H6 (EVALUATION METHOD CODES, EVALUATION METHOD CODES AND EVALUATION CONCLUSION CODES) HAVE BEEN CORRECTED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED IN (B)(6) 2021. IN FEBRUARY 2022, A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS PERFORMED TO EVALUATE A LUNG NODULE FOR A SEPARATE ISSUE. THE PET SCAN SHOWED A "HOT SPOT" IN THE DUODENUM AT THE SAME LOCATION AS THE ESD PERFORMED IN (B)(6) 2021. IT WAS STATED THAT THE PHYSICIAN ATTRIBUTED THIS FINDING TO ORISE INFLAMMATION. AS A RESULT OF THE FINDINGS ON THE PET SCAN, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH BIOPSY IN (B)(6) 2022. THE BIOPSY SHOWED "PEPTIC DUODENITIS WITH ULCERATION".