SUPER XL DELIVERY SYSTEM FOR AIR CONTRAST STUDIES

Additional Manufacturer Narrative

INVESTIGATION RESULTS: 1. LIQUID POLIBAR (LOT #10636): REVIEW OF THE MFG RECORDS FOR THE PRODUCT LOT IN QUESTION REVEALED THE BATCH WAS PRODUCED IN ACCORDANCE WITH MFG AND PACKAGING PROCEDURES. NOTHING UNUSUAL PERTAINING TO THE NATURE OF THIS COMPLAINT WAS NOTED. MICROBIOLOGICAL AND CHEMICAL TESTING OF A RETAIN SAMPLE REVEALED ALL TEST RESULTS TO BE WITHIN THE REQUIRED SPECS. 2. SUPER XL ENEMA KIT (LOT #10178925): REVIEW OF MFG RECORDS REVEALED ALL UNITS, SUB-ASSEMBLY PARTS, AND COMPONENTS TO BE WITHIN THE ESTABLISHED QUALITY REQUIREMENTS. A RETAIN SAMPLE FROM THE LOT IN QUESTION WAS NOT AVAILABLE. HOWEVER, INSPECTION OF PRODUCT MFG BEFORED AND AFTER THE LOT DID NOT REVEAL ANY DEFECTS. IT IS THE OPINION OF E-Z EM'S MED DIR THAT THIS EVENT REPRESENTS AN ANAPHYLACTIC TYPE ALLERGIC REACTION, MOST LIKELY TO THE LATEX GLOVES THAT THE MED PERSONNEL WERE WEARING, ALTHOUGH A REACTION TO ONE OF THE EXCIPIENTS IN THE BARIUM CAN NOT BE RULED OUT.