Description of Event or Problem · 1
PATIENT DESCRIBES NUMEROUS PHYSICAL AILMENTS OF HERSELF AND HER THREE CHILDREN SHE FEELS ARE DUE TO HER BREAST IMPLANTS. THIS IS THE SECOND PAIR OF IMPLANTS FOR THIS PATIENT. THESE WERE SURGICALLY REMOVED INTACT WITH NO OBVIOUS LEADAGE FOLLOWING PATHOLOGY EXAMINATION; HOWEVER, THEY WERE ATTACHED TO TISSUE. THE FIRST PAIR WERE IMPLANTED NOVEMBER 23, 1976; THEY DID RUPTURE AND WERE REMOVED ON JULY 24, 1978, WHEN THIS SECOND PAIR WAS THEN IMPLANTED. THE PATIENT'S PHYSICAL COMPLAINTS MAY BE ASSOCIATED WITH THE FIRST PAIR OF IMPLANTSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.