{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 18
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "SUITE 140",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "CA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "SUITE 140",
      "manufacturer_g1_city": "WESTLAKE VILLAGE",
      "manufacturer_contact_address_1": "4360 PARK TERRACE DRIVE",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "3003990090-2026-02079",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20260604",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K140843",
      "date_of_event": "20260505",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "91361",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "CURRAN",
      "source_type": [
        "Health Professional",
        "User facility",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "91361",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260604",
      "manufacturer_contact_f_name": "RYAN",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1455111",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20260604",
          "brand_name": "DESARA BLUE SS",
          "generic_name": "MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, SUI, RETROPUBIC OR",
          "manufacturer_d_name": "CALDERA MEDICAL, INC",
          "manufacturer_d_address_1": "4360 PARK TERRACE DRIVE",
          "manufacturer_d_address_2": "SUITE 140",
          "manufacturer_d_city": "WESTLAKE VILLAGE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "91361",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "91361",
          "device_operator": "",
          "model_number": "CAL-DS01BS",
          "catalog_number": "CAL-DS01BS",
          "lot_number": "R06068",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "OTN",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "00890594000735",
          "udi_public": "00890594000735",
          "openfda": {
            "device_name": "Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.3300",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Material Separation"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260618",
      "health_professional": "Y",
      "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": "20260604",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260604",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "WESTLAKE VILLAGE",
      "mdr_report_key": "25402521",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260505",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "91361",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "CALDERA MEDICAL, INC",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "404868937",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "CALDERA WAS NOTIFIED THAT TRIHEALTH (BETHESDA NORTH HOSPITAL) REPORTED AN ISSUE WITH A DESARA BLUE SS SLING, LOT R06068. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT, WHEN THE SURGEON WAS PUTTING THE TROCAR INTO THE LOOP, THE LOOP STITCHING BROKE. NO PATIENT INJURY, PROCEDURE IMPACT, DEVICE RETURN STATUS, SERIAL NUMBER, UDI, IMPLANT INFORMATION, TREATMENT, OR PATIENT OUTCOME WAS PROVIDED AT THE TIME OF THIS REPORT. THE FACILITY REQUESTED A REPLACEMENT PRODUCT. ADDITIONAL INFORMATION IS BEING REQUESTED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "4360 PARK TERRACE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "91361",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}