{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "OSTED",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "AAHOLMVEJ 1-3",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3003442380-2026-05511",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K032854",
      "date_of_event": "20260129",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "4320",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
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        "Distributor"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260331",
      "manufacturer_contact_f_name": "",
      "device_date_of_manufacturer": "20250107",
      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20260331",
          "brand_name": "INSET",
          "generic_name": "UNO INSET I 60/6 GREY TCAP 10PK INT",
          "manufacturer_d_name": "UNOMEDICAL DEVICES S.A. DE C.V.",
          "manufacturer_d_address_1": "AVE. FOMENTO INDUSTRIAL L9 M3",
          "manufacturer_d_address_2": "PARQUE INDUSTRIAL DEL NORTE",
          "manufacturer_d_city": "REYNOSA, TAMAULIPAS, C.P,",
          "manufacturer_d_state": "",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "MX",
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          "device_operator": "LAY USER/PATIENT",
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          "catalog_number": "",
          "lot_number": "6014160",
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          "device_availability": "No",
          "device_report_product_code": "FPA",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "05705244016620",
          "udi_public": "05705244016620",
          "openfda": {
            "device_name": "Set, Administration, Intravascular",
            "medical_specialty_description": "General Hospital",
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          }
        }
      ],
      "product_problems": [
        "Appropriate Device Problem Term/Code Not Available"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "DA",
      "date_changed": "20260401",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20260331",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "51 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hyperglycemia"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260302",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "LEJRE,",
      "mdr_report_key": "24737918",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260302",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "397138665",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INITIAL AND FINAL MDR (B)(4)-MDR 3003442380-2026-05511-DEVICE 1 OF 2."
        },
        {
          "mdr_text_key": "397138666",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INSULIN FLOW BLOCKED ALARM DUE TO OCCLUSION EVENT ON 29-JAN-2026. DUE TO OCCLUSION ISSUE, PATIENT'S BLOOD GLUCOSE LEVEL WAS HIGH AND WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS (MDI). THE PATIENT REPLACED SOFT CANNULA INFUSION SET ONLY AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "4320",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}