{
  "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": "2026-09-08",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MS.",
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      "manufacturer_contact_address_2": "",
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      "date_of_event": "20240523",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
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          "device_report_product_code": "FGB",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
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          "udi_public": "+B634MON0000070/16D20230821",
          "openfda": {
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      "reporter_state_code": "WI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250820",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          "sequence_number_outcome": [
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          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Abdominal Distention",
            "Adult Respiratory Distress Syndrome",
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        }
      ],
      "distributor_city": "",
      "date_report": "20240618",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "REDWOOD CITY",
      "mdr_report_key": "19559443",
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      "number_devices_in_event": "",
      "date_manufacturer_received": "20240612",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "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": "Y",
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      "mdr_text": [
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          "text_type_code": "Description of Event or Problem",
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        },
        {
          "mdr_text_key": "345026491",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE INVESTIGATION DETERMINED THE PROBABLE CAUSE IS RELATED TO ADDITIONAL IRRIGATION(OFF LABEL USE)THAT WAS USED DURING THE PROCEDURE. OUTCOME DOCUMENTED WAS RESOLVED WITHOUT SEQUELAE. THE REVIEW DETERMINED THAT THE ABDOMINAL DISTENTION AND RESPIRATORY DISTRESS IS NOT SERIOUS ADVERSE EVENT. IN ADDITION, THE CUSTOMER DID NOT REPORT ANY ISSUES WITH THE MONARCH SYSTEM THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "150 SHORELINE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "94065",
      "manufacturer_contact_exchange": "628",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}