PATIENT REPORTED "FEELING NO RESTRICTION AND HAVING TROUBLE KEEPING FOOD DOWN THAT STARTED FIVE YEARS AGO". PATIENT ALSO REPORTED DIAGNOSTIC IMAGING SHOWED "UNIDENTIFIED METAL OBJECTS" IN [PATIENT'S] ABDOMEN. NO TREATMENT HAS BEEN PROVIDED. ADDITIONAL FINDINGS: HEALTHCARE PROFESSIONAL REPORTED "NO FLUID IN THE BAND". DYSPHAGIA, VOMITING, AND "SCATTERED ROUNDED METALLIC OBJECTS IN ABDOMEN" WERE ALSO REPORTED, ALTHOUGH NO INTERVENTION HAS BEEN PROVIDED TO PRECLUDE DEATH OR PERMANENT IMPAIRMENT FOR THESE EVENTS, AND THEY ARE NOT CONSIDERED SERIOUS INJURIES.
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Patient 1
(B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN REC'D BY ALLERGAN. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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: DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT, OR THE CONNECTOR TUBING.