{
  "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": "2026-10-07",
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    {
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2135225-2008-00011",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20080221",
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      "pma_pmn_number": "",
      "date_of_event": "20080111",
      "reprocessed_and_reused_flag": "N",
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      "reporter_occupation_code": "NOT APPLICABLE",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20080227",
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      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080221",
          "brand_name": "RADIESSE DERMAL FILLER",
          "generic_name": "INJECTABLE IMPLANT",
          "manufacturer_d_name": "BIOFORM MEDICAL, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "FRANKSVILLE",
          "manufacturer_d_state": "WI",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "UNK",
          "catalog_number": "UNK",
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          "device_availability": "No",
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          "openfda": {
            "device_name": "Implant, Dermal, For Aesthetic Use",
            "medical_specialty_description": "Unknown",
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            "device_class": "3"
          }
        }
      ],
      "product_problems": [
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      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "health_professional": "",
      "summary_report_flag": "N",
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      "patient": [
        {
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          "date_received": "20080221",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Pain",
            "Skin Discoloration",
            "Drainage"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080220",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1001921",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080215",
      "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": "",
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      "mdr_text": [
        {
          "mdr_text_key": "780234",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE GLABELLAR. WHEN BEING INJECTED IT WAS VERY PAINFUL IN ONE INJECTION SITE. WHEN THE PT WAS AT HOME SHE NOTICED THE AREA HAD TURNED WHITE, FOUR DAYS LATER THE AREA STARTED DRAINING."
        },
        {
          "mdr_text_key": "8088011",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "PT REPORTED THAT SHE WAS INJECTED IN THE GLABELLA WITH RADIESSE DERMAL FILLER, WHEN SHE WAS INJECTED IT WAS VERY PAINFUL. WHEN THE PT WAS AT HOME THE AREA HAD TURNED WHITE. FOUR DAYS LATER THE AREA BEGAN DRAINING. PT RETURNED TO THE INJECTING PHYSICIAN AND WAS DIAGNOSED WITH A CELLULITIS AND AN OCCLUDED VEIN. THE PT WAS PRESCRIBED AZROTHMYCIN PO, BID, NITRO-BID OINTMENT AND BACTROCIN TOPICAL OINTMENT. THE AREA IS HEALING WITH OUT PROBLEMS. INJECTION INTO THE GLABELLA IS AN OFF LABEL USE."
        }
      ],
      "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": ""
    }
  ]
}