{
  "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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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K050604",
      "date_of_event": "20170411",
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      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200508",
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      "device": [
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          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "501817",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200508",
          "brand_name": "EXTRUDE VPS",
          "generic_name": "IMPRESSION MATERIAL",
          "manufacturer_d_name": "KERR CORPORATION",
          "manufacturer_d_address_1": "28200 WICK ROAD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ROMULUS, MI",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
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          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "ELW",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Material, Impression",
            "medical_specialty_description": "Dental",
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      "product_problems": [
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200508",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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            " R"
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          "patient_age": "",
          "patient_sex": "",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Foreign Body In Patient"
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        }
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      "distributor_city": "",
      "date_report": "20200508",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10041042",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200415",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "190494662",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "AN ALLEGED COMPLAINT WAS REPORTED THAT A PATIENT SWALLOWED THE KERR EXTRUDE MIDDLE BODY VPS DURING THE PROCEDURE ON (B)(6) 2017. PATIENT EXPERIENCED GASTROINTESTINAL COMPLAINTS ATTRIBUTABLE TO THE IMPRESSION MATERIAL. A FEW DAYS AFTER THE PROCEDURE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2017 TO REMOVE THE SWALLOWED IMPRESSION MATERIAL. NO INFORMATION WAS PROVIDED IN REGARDS TO WEIGHT, AGE, ETHNICITY AND RACE. NO INFORMATION WAS PROVIDED IN REGARDS TO LOT NUMBER, THEREFORE DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE NO FURTHER EVALUATION COULD BE DONE."
        },
        {
          "mdr_text_key": "190494663",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A COMPLAINANT ALLEGED A PATIENT SWALLOWED DENTAL MATERIAL, WHICH CAUSED BOWEL OBSTRUCTION."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}