ORISE GEL

Description of Event or Problem

BOSTON SCIENTIFIC CORPORATION BECAME AWARE THAT ORISE GEL WAS USED AS A LIFTING AGENT ON AN UNKNOWN DATE VIA A SOCIAL MEDIA TWITTER POST. ACCORDING TO THE LIMITED INFORMATION AVAILABLE FROM THE POST, A PATIENT UNDERWENT A RESECTION FOLLOWING A POLYPECTOMY. THE SPECIMEN SHOWED "AMORPHOUS PINK STUFF ASSOCIATED WITH A WHOPPING FOREIGN BODY-TYPE GIANT CELL REACTION." IT IS NOT KNOWN IF THE RESECTION WAS DUE TO ORISE GEL. 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

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 UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4).