{
  "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": "2026-07-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
      "manufacturer_contact_t_name": "",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200520",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200629",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "667919",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200626",
          "brand_name": "HYDRAFACIAL",
          "generic_name": "POWERED LASER SURGICAL INSTRUMENT",
          "manufacturer_d_name": "HYDRAFACIAL/EDGE SYSTEMS LLC",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "GEX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "Y",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Powered Laser Surgical Instrument",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
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      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "NJ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "date_received": "20200626",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "48 YR",
          "patient_sex": "",
          "patient_weight": "70",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Erythema",
            "Deformity/ Disfigurement",
            "Erythema",
            "Deformity/ Disfigurement"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200625",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10206158",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary 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": "197146275",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "I HAD A HYDRAFACIAL PROCEDURE DONE AND THE NEXT DAY MY FACE APPEARED REDDISH IN COLOR WITH A BREAKOUT ON MY ENTIRE FACE. I AM AFRICAN AMERICAN WITH DARK COLORED SKIN AND THE REDDISH COLOR APPEARS TO BE PERMANENT DAMAGE TO MY SKIN. DR. SHEILA BOND, A PLASTIC SURGEON SUPERVISED THE PROCEDURE BUT DID NOT DIRECTLY ADDRESS THE ADVERSE REACTIONS OF THE PROCEDURE WHEN REPORTED TO HER."
        }
      ],
      "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": ""
    }
  ]
}