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Patient 1
TO DATE WE HAVE NOT BEEN ABLE TO CONFIRM THAT THE LEECHES INVOLVED IN THIS EVENT WERE SUPPLIED BY (B)(4). LEECHES HAVE NEVER BEEN SUPPLIED TO (B)(6). ATTEMPTS TO OBTAIN ADD'L INFO ARE ONGOING AND WILL BE COMMUNICATED, IF SUCCESSFUL, BY MEANS OF A FOLLOW-UP REPORT. INFECTION FROM OUTSIDE SOURCES, INCLUDING THE AIR, WATER AND THE LEECH ITSELF, IS A WELL-KNOWN RISK TO PTS RECEIVING LEECH THERAPY. PROPHYLAXIS WITH AN APPROPRIATE ANTIBIOTIC IS RECOMMENDED BY SPECIALIZED STUDIES. A WARNING TO THIS EFFECT IS INCLUDED ON PAGE 4 OF OUR PACKAGE INSERT, AS WELL AS A LIST OF ANTIBIOTICS ON PAGE 6, AS REQUIRED AND CLEARED BY FDA FOR (B)(4). THE PACKAGE INSERT CONSISTING OF INSTRUCTION FOR USE AND A LIST OF ANTIBIOTICS AGAINST AEROMONAS HYDROPHILA IS INCLUDED WITH EVERY SHIPMENT OF LEECHES. COINCIDENTALLY WITH THE EVENT, OUR PACKAGE INSERT WAS REVISED TO CORRECT THE STATEMENT THAT HAD PREVIOUSLY IDENTIFIED CIPROFLOXACIN, TRIMETHOPRIM/SULFAMETHOZAZOLE AND CEFOTAXIME INCORRECTLY AS THIRD GENERATION CEPHALO-SPORINS. HOWEVER, WE CONSIDER THAT THIS ERRONEOUS STATEMENT COULD NOT HAVE CONTRIBUTED TO THE EVENT ASSUMING THAT OUR LEECHES WERE INVOLVED AND THAT OUR PREVIOUS INSERT WAS CONSULTED, SINCE THE ANTIBIOTICS THUS IDENTIFIED HAVE BEEN -AND CONTINUE TO BE- AMPLY RECOMMENDED FOR PROPHYLAXIS BY SPECIALIZED STUDIES REGARDING THE RISK OF INFECTION CONCOMITANT TO LEECH THERAPY. WE ARE INCLUDING A CURRENT COPY OF OUR PACKAGE INSERT WITH THIS REPORT AND WILL CONTINUE OUR ATTEMPTS TO CLARIFY THE CIRCUMSTANCES PERTAINING TO THIS EVENT.