{ "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 INDICATED THAT APPROXIMATELY 1 WEEK AFTER THEIR PROCEDURE, ON (B)(6) 2012, THE PATIENT BECAME VERY ILL AND EXPERIENCED PAIN AND WAS ADMITTED INTO (B)(6) MEDICAL CENTER FOR A SLEEPING BOWEL. PER THE PATIENT, HER BELLY WAS FILLED WITH FLUID AND REQUIRED DRAINING. UPON RETURNING HOME THE PATIENT THREW UP, EXPERIENCED A FULL BELLY, AND CONTINUED TO FEEL ILL. THE PATIENT WAS ADVISED HER SYMPTOMS WERE A NATURAL RESPONSE TO HER PROCEDURE. ON (B)(6) 2012, THE PATIENT WAS ADMITTED INTO THE ER AND A CAT SCAN FOUND FLUID, HOWEVER NO DRAINAGE WAS PERFORMED. THE ATTENDING PHYSICIAN RELEASED THE PATIENT AND ADVISED THE PATIENT THAT THE SYMPTOMS WERE THE RESULT OF AN INFLAMMATORY CONDITION. PER THE PATIENT, ON (B)(6) 2012, ONE-LITER OF FLUID WAS DRAINED FROM HER STOMACH AND SHE WAS PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. PER THE PATIENT, DYE TESTS PERFORMED REVEALED THAT HER URETER WAS NICKED. PER THE PATIENT A STENT WAS PLACED IN HER URETER, AN ABDOMINAL DRAIN AND CATHETER WERE PLACED TO REPAIR HER URETER. NO FURTHER DETAILS WERE PROVIDED." }, { "mdr_text_key": "10449876", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "10113591", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "POSTOPERATIVE SIDE EFFECTS ARE KNOWN AND ASSESSED NORMAL RISKS OF SURGICAL PROCEDURES, AND CAN DEVELOP REGARDLESS OF THE MODALITY USED TO PERFORM THE SURGERY. PER THE INFORMATION PROVIDED, NO SYSTEM MALFUNCTIONS WERE ALLEGED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE TO THE PHYSICIAN, HOWEVER DUE TO LITIGATION INVOLVING THIS CASE, NO FURTHER INFORMATION WAS PROVIDED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. 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": "01/10/2013" } ] }