{
  "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": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2280705-2020-00016",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200526",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K895640",
      "date_of_event": "20200508",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "CONSUMER"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20200526",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "549667",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200526",
          "brand_name": "TROJAN MAGNUM THIN CONDOMS",
          "generic_name": "CONDOM",
          "manufacturer_d_name": "CHURCH & DWIGHT CO., INC.",
          "manufacturer_d_address_1": "500 CHARLES EWING BOULEVARD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "EWING, NJ",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "2260064614",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "HIS",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00022600646143",
          "udi_public": "00022600646143",
          "openfda": {
            "device_name": "Condom",
            "medical_specialty_description": "Obstetrics/Gynecology",
            "regulation_number": "884.5300",
            "device_class": "2",
            "registration_number": [
              "2280705"
            ],
            "fei_number": [
              "2280705"
            ]
          }
        }
      ],
      "product_problems": [
        "Break",
        "Product Quality Problem"
      ],
      "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",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200526",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "40 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Urinary Tract Infection",
            "Urinary Tract Infection"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200526",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10087806",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200514",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "192021387",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE CONSUMER ALLEGES THAT ALL THREE CONDOMS IN THE BOX BROKE. THE CONDOMS BROKE NEAR THE TIP AND AROUND THE CIRCUMFERENCE DURING INTERCOURSE. HE BEGAN USING THE CONDOMS FROM THIS PARTICULAR BOX ON (B)(6) 2020 AND FINISHED USING ALL OF THE CONDOMS ON (B)(6) 2020. HE ALSO BELIEVES THAT HE CONTRACTED A URINARY TRACT INFECTION FROM THESE CONDOMS. HE FURTHER EXPLAINED THAT STARTING ON (B)(6) 2020, HE EXPERIENCED BURNING WITH URINATION. AS OF (B)(6) 2020 (WHEN HE CONTACTED US), HE IS STILL EXPERIENCING THESE SYMPTOMS. HE DID NOT SEEK MEDICAL ATTENTION."
        }
      ],
      "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": ""
    }
  ]
}