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Patient 1
TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER 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 A DAMAGED DEVICE: "THE LAP-BAND AP SYSTEM IS FOR SINGLE USE ONLY. DO NOT USE A BAND, ACCESS PORT, NEEDLE OR CALIBRATION TUBE WHICH APPEARS DAMAGED (CUT, TORN, ETC.) IN ANY WAY. DO NOT USE ONE OF THEM IF THE PACKAGE HAS BEEN OPENED OR DAMAGED, OR IF THERE IS ANY EVIDENCE OF TAMPERING. IF PACKAGING HAS BEEN DAMAGED, THE PRODUCT MAY NOT BE STERILE AND MAY CAUSE AN INFECTION." "CAUTION: THE BAND, ACCESS PORT AND CALIBRATION TUBE MAY BE DAMAGED BY SHARP OBJECTS AND MANIPULATION WITH INSTRUMENTS. A DAMAGED DEVICE MUST NOT BE IMPLANTED. FOR THIS REASON, A STAND-BY DEVICE SHOULD BE AVAILABLE AT THE TIME OF SURGERY."