{
  "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-07",
    "results": {
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      "manufacturer_contact_zip_ext": "",
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      "event_location": "I",
      "report_to_fda": "*",
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      "manufacturer_link_flag": "Y",
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      "reporter_occupation_code": "OTHER",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "CH",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "465756",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "NI",
          "generic_name": "SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE",
          "manufacturer_d_name": "BAXTER HEALTHCARE CORPORATION",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "DEERFIELD",
          "manufacturer_d_state": "IL",
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          "manufacturer_d_zip_code_ext": "",
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          "device_operator": "LAY USER/PATIENT",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
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            "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable",
            "medical_specialty_description": "Gastroenterology, Urology",
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        "Adverse Event Without Identified Device or Use Problem"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
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          "patient_sequence_number": "1",
          "date_received": "20200427",
          "sequence_number_treatment": [
            "DIANEAL"
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          "sequence_number_outcome": [
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          "patient_age": "47 YR",
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          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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        }
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      "distributor_city": "",
      "date_report": "20200427",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000057",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200403",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "188969185",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED."
        },
        {
          "mdr_text_key": "188969186",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A PERITONEAL INFECTION. THE CAUSE WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. THE PATIENT WAS TREATED WITH VORICONAZOLE (INTRAPERITONEALLY, DOSE, FREQUENCY AND DURATION WERE NOT REPORTED) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT RECOVERED FROM THE EVENT. PD THERAPY WAS WITHDRAWN. NO ADDITIONAL INFORMATION IS AVAILABLE AS THE REPORTER DECLINED FOLLOW UP."
        }
      ],
      "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": ""
    }
  ]
}