{ "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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THE PATIENT WAS HOSPITALIZED DUE TO PAIN IN THE RIGHT GROIN. A CONTRAST CT WAS ASSESSED AND DIAGNOSIS OF RETROPERITONEAL HEMATOMA WAS MADE. THE SIZE OF THE HEMATOMA DECREASED EACH DAY AND REHABILITATION WAS INTRODUCED THE LAST 7 DAYS. THE PATIENT WAS DISCHARGED. (B)(6)." }, { "mdr_text_key": "315552828", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED." }, { "mdr_text_key": "315552829", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FURTHER INFORMATION CONFIRMED THAT THE PHYSICIAN DOES NOT ATTRIBUTE THE HEMATOMA TO THE CATHETER OR THE INTRODUCER. IT WAS INDICATED THE CAUSE MAY HAVE BEEN THE ANTICOAGULATION OR THE PUNCTURE NEEDLE/GUIDEWIRE. IT IS STILL UNKNOWN THE CAUSE FOR THE HEMATOMA. FURTHER INFORMATION HAS NOT BEEN PROVIDED." }, { "mdr_text_key": "314987508", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FURTHER INFORMATION CONFIRMED THE PUNCTURE NEEDLE/GUIDEWIRE WERE NON-ABBOTT DEVICES." } ], "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": "05/26/2020;05/28/2020" } ] }