{
  "meta": {
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    "terms": "https://open.fda.gov/terms/",
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      "manufacturer_contact_area_code": "",
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          "generic_name": "ZIO PATCH",
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          "manufacturer_d_address_1": "699 8TH ST",
          "manufacturer_d_address_2": "SUITE 600",
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      "date_changed": "20250814",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000878",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200404",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "adverse_event_flag": "Y",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "190121294",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. CLINICAL REF. MANUAL (N100A4010.04) WARNINGS STATE THE FOLLOWING: DO NOT USE THE ZIO XT PATCH ON PATIENTS WITH KNOWN ALLERGIC REACTION TO ADHESIVES OR HYDROGELS OR WITH FAMILY HISTORY OF ADHESIVE SKIN ALLERGIES. PATIENT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION SUCH AS SEVERE REDNESS, ITCHING OR ALLERGIC SYMPTOMS DEVELOP, REMOVE THE ZIO XT PATCH FROM THE PATIENT'S CHEST."
        },
        {
          "mdr_text_key": "190121295",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A PROBABLE CONTACT DERMATITIS WHERE TREATMENT WAS PRESCRIBED."
        }
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}