{
  "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",
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      "manufacturer_contact_zip_ext": "",
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      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
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      "manufacturer_g1_state": "",
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          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
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          "manufacturer_d_state": "IL",
          "manufacturer_d_zip_code": "",
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          "device_evaluated_by_manufacturer": "",
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          "udi_di": "",
          "udi_public": "",
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        "Fluid/Blood Leak"
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      "reporter_state_code": "TN",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "No Consequences Or Impact To Patient"
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        }
      ],
      "distributor_city": "",
      "date_report": "20200427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20200427",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000087",
      "removal_correction_number": "",
      "number_devices_in_event": "",
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      "date_report_to_fda": "20200427",
      "manufacturer_name": "",
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      "remedial_action": [
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      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
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          "mdr_text_key": "190158755",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE REPORTED PRODUCT WAS A PRISMAFLEX SET. (B)(6). 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": "190158757",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX SET, A LOSS LIMIT REACHED ALARM WAS TRIGGERED DUE TO LEAKING BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}