{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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IT IS ALSO ALLEGED THAT DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED PERFORATION OF THE PANCREAS. THE SURGEON DECIDED TO CONVERT THE PARTIAL NEPHRECTOMY PROCEDURE TO A RADICAL NEPHRECTOMY PROCEDURE. A SPECIALIST WAS CALLED IN TO ASSIST WITH IDENTIFICATION AND REPAIR OF THE DAMAGE ORGANS AND VESSELS. IT IS ALLEGED THAT BETWEEN (B)(6) 2010 AS RESULTS OF THE VARIOUS INJURIES AND IN PARTICULAR THE UNREPAIRED AND UNTREATED INJURY TO THE PANCREAS, HEMORRHAGIC DEBRIS AND FLUID ACCUMULATED IN THE CONTIGUOUS RESIDUAL CAVITY, CAUSING AND/OR CONTRIBUTING TO THE DEVELOPMENT OF A RIGHT PLEURAL EFFUSION AND PERICARDIAL EFFUSION. ON SEPTEMBER 28TH, 2012, ISI BECAME AWARE THAT THE PATIENT EXPIRED ON (B)(6) 2010." }, { "mdr_text_key": "10247021", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AT THIS TIME IT IS UNDETERMINED AS TO WHAT CAUSED THE PATIENT'S DEATH. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THIS SITE WITHOUT SUCCESS. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }