Description of Event or Problem · 1
FAILED MEDICAL DEVICE. IMPLANTED 6/90. PUS AROUND IMPLANT SINCE 11/92; DR DID NOT ADVISE REMOVAL EVEN THOUGH HE KNEW RPTR HAD MITRAL VALVE PROLAPSE. 8/95 UPON AWAKENING, RIGHT UPPER LIP AND TISSUE IN AREA ADJACENT TO IMPLANT SWOLLEN; SEVERE PAIN IN UPPER AND LOWER JAW; SYSTEMICALLY ILL; WENT TO DR WHO PRESCRIBED ANTIBIOTICS AND DIAGNOSIS OF JAW ABSCESSES FROM IMPLANT; WENT TO DDS FOR EMERGENCY; TREATED WITH ANTIBIOTICS; INFECTION REMAINED AND EXPLANTED 8/95; RESULTANT SEVERE BONE LOSS. RPTR CLAIMS TO HAVE BEEN INJURED BY MFR WITH MEDICAL DEVICES THAT WERE ALL INSERTED WITHOUT HER INFORMED CONSENT. SHE FEELS SHE HAS BEEN USED AS A GUINEA PIG WITH FEDERAL RESEARCH AND EDUCATIONAL GRANTS AND SHE NEEDS SURGICAL TREATMENT FOR THE MULTIPLE INJURIES SHE HAS RECEIVED FROM THE EXPERIMENTS WITH THE INVESTIGATIONAL DEVICES AND PRODUCTS. SHE HAS SPENT APPROX $53,000 ON HER JAWS FROM THE PRODUCTS AND INJURIES. PER RPTR THE MFR HAS REFUSED TO ABIDE BY GMP REQUIREMENTS AND HAS FOUGHT HER WITH A STAFF OF SIX ATTYS FOR YEARS. HER HEALTH IS DETERIORATING FROM LACK OF MEDICAL TREATMENT TO ATTEMPT TO CORRECT MY INJURIES FROM THE EXPERIMENTS. IT IS HER UNDERSTANDING THAT SHE SHOULD BE SENT TO A MEDICAL DR TO RECEIVE THE TREATMENT SHE NEEDS UNDER THE TERMS OF THE FEDERAL RESEARCH AND EDUCATION GRANTS.