ORISE GEL
Received Nov 15, 2022 · Event occurred Oct 1, 2022
Report 3005099803-2022-06636 · MDR key 15801227
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
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PHYSICIAN HAD A PATIENT WHO EXPERIENCED A FOREIGN BODY REACTION, AND REFERRED THEM TO ANOTHER PHYSICIAN WHO RECOGNIZED IT AS A REACTION TO ORISE GEL. IT WAS MENTIONED THAT THE REFERRED PHYSICIAN HAD THE SAME ISSUE WITH ORISE IN A COUPLE OF PATIENTS A FEW YEARS AGO. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
DATE OF EVENT: 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. DEVICE MANUFACTURE DATE: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IMPACT CODE: (B)(4).
Remedial action
- Other