ORISE GEL
Received Dec 5, 2022 · Event occurred Nov 1, 2022
Report 3005099803-2022-07077 · MDR key 15920931
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Granuloma
- Granuloma
Narrative
Additional Manufacturer Narrative
THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4).
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ROUGHLY 6 MONTHS LATER (B)(6)2022) DURING A FOLLOW-UP PROCEDURE, THE PHYSICIAN NOTICED A FOREIGN-BODY REACTION AT THE INJECTION SITE. IT WAS REPORTED THAT BIOPSIES WERE TAKEN DUE TO THE FOREIGN BODY REACTION. REPORTEDLY, PHYSICIANS AT THIS ACCOUNT ARE UNCOMFORTABLE USING ORISE GEL AT THE MOMENT AS THEY FEEL IT'S ADDING RISK FOR THEIR PATIENTS.
Remedial action
- Notification