Description of Event or Problem · 1
PATIENT COMPLAINED OF A LOSS OF VOLUME OF THE RIGHT BREAST IMPLANT OVER THE LAST TWO (2) YEARS. SHE ALSO HAD ARTHRITIS-LIKE SYMPTOMS AND OCCASIONAL DIZZINESS. CONCERNED ABOUT SILICONE LEAKAGE AND POSSIBLY BODILY DAMAGES SHE ELECTED THE REMOVAL AND REPLACEMENT WITH SALINE-FILLED IMPLANTS. THE RIGHT IMPLANT WAS FOUND TO BE COMPLETELY RUPTURED. THE LEFT IMPLANT WAS FOUND TO BE INTACT BUT ALSO WAS REMOVED AND REPLACED. BOTH IMPLANTS WERE GIVEN TO THE PATIENT POSTOPERATIVELY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.