{
  "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": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "HOSPITAL",
      "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": "Malfunction",
      "report_number": "1017072-2008-00006",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080219",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20080119",
      "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": [
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080506",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080219",
          "brand_name": "SCD EXPRESS SLEEVE K/L MEDIUM",
          "generic_name": "SCD SLEEVE",
          "manufacturer_d_name": "TYCO HEALTHCARE/ KENDALL",
          "manufacturer_d_address_1": "1448 BLUE RIDGE BOULEVARD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SENECA",
          "manufacturer_d_state": "SC",
          "manufacturer_d_zip_code": "29672",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "29672",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "0000217715",
          "catalog_number": "9529",
          "lot_number": "UNK",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "JOW",
          "device_age_text": "NA",
          "device_evaluated_by_manufacturer": "*",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Sleeve, Limb, Compressible",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.5800",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Other (for use when an appropriate device code cannot be identified)"
      ],
      "reporter_state_code": "VA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "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": "20080219",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "30 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Bruise/Contusion"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080121",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20080121",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1001354",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080121",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "801128",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED TO TYCO KENDALL/HEALTHCARE THAT A CUSTOMER HAD A PROBLEM WITH THE SCD SLEEVE. THE CUSTOMER REPORTS \"MALE WITH AORTIC DISSECTION AND BOWEL INJURIES, PATIENT HAD BRUISING (ECCHYMOSIS HORIZONTAL MARKINGS).\""
        },
        {
          "mdr_text_key": "8093532",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED."
        }
      ],
      "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": ""
    }
  ]
}