Description of Event or Problem · 1
PATIENT HAD LEFT BREAST RECONSTRUCTION FOR HYPOPLASTIC BREAST AND RIGHT BREAST AUGMENTATION IN 1978. ON OR ABOUT MARCH 24, 1992 SHE WA WRESTLING AND HEARD A POP. MAMOGRAM REVEALED A RUPTURED LEFT BREAST IMPLANT. A REMOVAL OF LEFT AND RIGHT IMPLANTS WAS DONE WITH REPLACEMENTS OF SALINE IMPLANTS. LEFT IMPLANT REMOVED WITHOUT LOSS OF SIGNIFICANT GEL MATERAL. NO LEAKAGE NOTED FROM RIGHT GEL IMPLANT. GEL DESCRIBED AS A STICKY AND WHITE SILICONE MATERAL IN PATHOLOGY REPORTDEVICE 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. 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, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: UNANTICIPATED. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.