Description of Event or Problem · 1
PATIENT HAD ORIGINAL BREAST IMPLANTS IN ANOTHER INSTITUTION IN 1984 WITH REVISION OF IMPLANTS IN ANOTHER INSTITUTION IN 1986. PRESENTED TO PHYSICIAN'S OFFICE WITH COMPLANTS OF BILATERAL LOSS OF BREAST VOLUME AND BILATERAL CAPSULAR CONTRACTURES. PATIENT ELECTED FOR REMOVAL OF GEL IMPLANTS AND REINSERTION OF SALINE IMPLANTS ON APRIL 13, 1993.BIL. CAPSULAR CONT.; LOSS OF IMPLANT VOLUMEDEVICE LABELED FOR SINGLE USE. 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. 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: MATERIAL DEGRADATION/DETERIORATION, UNANTICIPATED ADVERSE REACTION - LONG TERM. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.