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Patient 1
NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, EXPLANT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA SYSTEM INCLUDE: INTESTINAL OBSTRUCTION BY THE BALLOON AN INSUFFICIENTLY INFLATED BALLOON OR A LEAKING BALLOON THAT HAS LOST SUFFICIENT VOLUME MAY BE ABLE TO PASS FROM THE STOMACH INTO THE SMALL BOWEL. IT MAY PASS ALL THE WAY THROUGH INTO THE COLON AND BE PASSED WITH STOOL. HOWEVER, IF THERE SHOULD BE A NARROW AREA IN THE BOWEL, AS MIGHT OCCUR AFTER PRIOR SURGERY ON THE BOWEL OR ADHESION FORMATION, THE BALLOON MAY NOT PASS THEN MAY CAUSE A BOWEL OBSTRUCTION. IF THIS OCCURS, PERCUTANEOUS DRAINAGE, SURGERY OR ENDOSCOPIC REMOVAL COULD BE REQUIRED. ANY BALLOONS WHICH LEAK SHOULD BE RETURNED TO ALLERGAN WITH A COMPLETE RETURNED PRODUCT FIELD NOTE DESCRIBING THE EVENT. YOUR ASSISTANCE WITH OUR CONTINUING QUALITY IMPROVEMENT EFFORTS IS APPRECIATED. WARNING: RAPID FILL RATES WILL GENERATE HIGH PRESSURE WHICH CAN DAMAGE THE ORBERA SYSTEM VALVE OR CAUSE PREMATURE DETACHMENT. A BALLOON WITH A LEAKING VALVE MUST BE REMOVED IMMEDIATELY. A DEFLATED BALLOON CAN RESULTS IN A BOWEL OBSTRUCTION, WHICH CAN RESULT IN DEATH. BOWEL OBSTRUCTIONS HAVE OCCURRED AS A RESULT OF UNRECOGNIZED OR UNTREATED BALLOON DEFLATION. ORBERA SYSTEM PLACEMENT AND INFLATION (STEP-BY-STEP): GENTLY PULL THE TUBING OUT AND CHECK VALVE FOR LEAKAGE.