EMBOSPHERE®

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. ABDOMINAL PAIN IS ONE OF THE MOST FREQUENTLY ANTICIPATED POST PROCEDURE COMPLICATIONS LISTED IN THE PRODUCT'S INSTRUCTION FOR USE KNOWN AS "POST-EMBOLIZATION SYNDROME. THIS ANTICIPATED COMPLICATION HAS ALREADY BEEN IDENTIFIED IN THE PRODUCT'S RISK MANAGEMENT FILE AND THE CURRENT ASSESSMENT STILL ADEQUATE.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

Description of Event or Problem

THE ACCOUNT ALLEGES POST A BILATERAL UTERINE ARTERY EMBOLIZATION PROCEDURE THE PATIENT EXPERIENCED SEVERE POSTOPERATIVE ABDOMINAL PAIN, WHICH REQUIRED ORAL NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, PTERIDINE INTRAMURAL INJECTION, AND MORPHINE SUBCUTANEOUS INJECTION FOR PAIN RELIEF. AFTER ABOVE TREATMENT, ABDOMINAL PAIN WAS GRADUALLY RELIEVED. NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.