ORISE GEL

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMPACT CODE F13: MISDIAGNOSIS/ MISCLASSIFICATION IS BEING USED TO CAPTURE THE FALSELY REPORTED T3 TUMOR. BLOCK H2: CORRECTION BLOCK H6 IMDRF IMPACT CODE F2203 IMAGING REQUIRED WAS ADDED. BLOCK H11 THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED, FOR THIS REASON AND DUE TO THE LACK OF EVIDENCE IS UNABLE TO CONFIRM THE REPORTED EVENT. A RISK REVIEW OF THE ORISE GEL WAS COMPLETED USING ORISE GEL HAZARD ANALYSIS AND CONFIRMED THAT THE EVENT OF "GRANULOMA" WAS DEFINED IN THE RISK/HAZARD DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK/HAZARD ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE INFORMATION PROVIDED, "GRANULOMA" ADVERSE EVENT IS KNOWN AND DOCUMENTED IN THE HAZARD DOCUMENTATION AND ALL REASONABLE STEPS HAVE BEEN TAKEN. IN THE OTHER HAND, THE AS REPORTED IMPACT CODES OF "UNEXPECTED MEDICAL INTERVENTION", "MISDIAGNOSIS/ MISCLASSIFICATION" AND "IMAGING REQUIRED" WILL BE CLASSIFIED AS "CAUSE NOT ESTABLISHED" SINCE THERE IS NOT ENOUGH INFORMATION TO CLARIFY WHY THIS EVENT HAPPENED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT ON AN UNKNOWN DATE. A SUBSEQUENT MRI FALSELY REPORTED T3 TUMOR. THERE ARE NO DETAILS ON ANY ADDITIONAL INTERVENTION TAKEN. 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.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT ON AN UNKNOWN DATE. A SUBSEQUENT MRI FALSELY REPORTED T3 TUMOR. THERE ARE NO DETAILS ON ANY ADDITIONAL INTERVENTION TAKEN. 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).