{
  "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": "2026-09-29",
    "results": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "manufacturer_contact_t_name": "MS.",
      "manufacturer_contact_state": "",
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      "manufacturer_contact_address_2": "OSTED",
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      "manufacturer_contact_address_1": "AAHOLMVEJ 1 - 3",
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      "pma_pmn_number": "K032854",
      "date_of_event": "20260501",
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "88736",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20260603",
          "brand_name": "INSET II",
          "generic_name": "SET, ADMINISTRATION, INTRAVASCULAR",
          "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",
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          "lot_number": "6017293",
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          "device_availability": "No",
          "device_report_product_code": "FPA",
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          "device_evaluated_by_manufacturer": "N",
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          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Set, Administration, Intravascular",
            "medical_specialty_description": "General Hospital",
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      ],
      "product_problems": [
        "Complete Blockage",
        "Material Twisted/Bent"
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      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "DA",
      "date_changed": "20260806",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
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          "date_received": "20260603",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          "patient_age": "NA",
          "patient_sex": "Female",
          "patient_weight": "72 KG",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hyperglycemia"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260504",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "MX",
      "manufacturer_contact_city": "LEJRE",
      "mdr_report_key": "25369272",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260504",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "88736",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "UNOMEDICAL DEVICES S.A DE C.V",
      "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": "403118922",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THREE INFUSION SET BENT CANNULA EVENT ON (B)(6) 2026. THE INSERTION SITE WAS THE ABDOMEN. PATIENT ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT AND PATIENT TOOK PUMP AND CHANGE INFUSION SET TO RESOLVE THE ISSUE."
        },
        {
          "mdr_text_key": "403118923",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INITIAL 2 OF 3. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "AVE.FOMENTO INDUSTRIAL L9 M3",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "4320",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}