{
  "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": "2026-08-05",
    "results": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "event_location": "NO INFORMATION",
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      "date_added": "20200917",
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      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1003768",
          "implant_date_year": "",
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          "serviced_by_3rd_party_flag": "",
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          "brand_name": "MAXITEMP HR 4:1",
          "generic_name": "CROWN AND BRIDGE, TEMPORARY, RESIN",
          "manufacturer_d_name": "HENRY SCHEIN, INC.",
          "manufacturer_d_address_1": "135 DURYEA ROAD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MELVILLE",
          "manufacturer_d_state": "NY",
          "manufacturer_d_zip_code": "11747",
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          "manufacturer_d_country": "US",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "Y",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Crown And Bridge, Temporary, Resin",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.3770",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Patient-Device Incompatibility"
      ],
      "reporter_state_code": "NJ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250730",
      "health_professional": "",
      "summary_report_flag": "N",
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      "patient": [
        {
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          "date_received": "20200916",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "50 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hypersensitivity/Allergic reaction",
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            "Hypersensitivity/Allergic reaction",
            "Swelling"
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      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10546311",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "Y",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "207535104",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DENTAL PROCEDURE FOR CROWNS ON BOTTOM TEETH RESULTED IN SEVERE ALLERGIC REACTION - THROAT SWELLING. TOOK 75 MG BENADRYL AND GOT IV OF SOLUMEDROL AT ER. EXPOSED TO MAXITEMP HR 4:1 WHICH IS GLASS FILTER MATERIALS IN A MATRIX OF MULTIFUNCTIONAL METHACRYLATES; CATALYST, STABILIZERS, ADDITIVES, FREE OF METHYL METHACRYLATE AND PEROXIDES. FILLER CONTENT: 47% BY WEIGHT =26% BY VOLUME. THE VARIATION WIDTH OF THE INORGANIC FILLER PARTICLES IS BETWEEN 0.02 AND 2.5 UM)."
        }
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}